BIBLIOTECA VIRTUAL DE CIÊNCIAS HUMANAS
BIOTECHNOLOGY
NOLOGY IN EUROPE
AND LATIN AMERICA
PROSPECTS FOR CO-OPERATION
Bernardo Sorj
Mark Cantley
Karl Simpson
Editors
Bernardo Sorj
Mark Cantley
Karl Simpson
Editors
Biotechnology
chnology in Europe
and Latin
tin America
This publication is part of The Virtual Library of Social Sciences of The Edelstein
Center for Social Research - www.bvce.org
Copyright © 2010, Mark Cantley, Karl Simpson, Bernardo Sorj
Copyright © 2010 of this on-line edition: The Edelstein Center for Social Research
Prospects for co-operation
operation
No part of this publication may be reproduced or transmitted for commercial
purposes in any form or by any means without permission in writing from the
copyright holder at the address below. Parts of this publication may be reproduced
for non commercial purposes so long as the authors and publisher are duly
acknowledged.
ISBN 978-85-7582-036-6
Rio de Janeiro
2010
The Edelstein Center for Social Research
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Rua Visconde de Pirajá, 330/1205
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Contact: [email protected]
SUMMARY
Preface ....................................................................................................... III
Welcoming Speech .......................................................................................1
Karl-Heinz Narjes
1.10. Spain ............................................................................................ 107
Armando Albert
1.11. The United Kingdom ................................................................... 113
Roy Smither
Remarks........................................................................................................7
Phili Viehoff
Introduction .................................................................................................9
Karl Simpson
SECTION TWO – Biotechnology in Latin America ........................... 124
Comments ............................................................................................. 125
Luis Ramiro Alfonsin
2.0. Overview of Latin American Activities in Biotechnology ........... 129
SECTION ONE – Biotechnology in Europe ...........................................21
1.0. Overview of European Activities in Biotechnology ........................22
Karl Simpson
1.1. Belgium ............................................................................................29
Adapted from speech made by Mr C. de Wispelaere
1.2. Denmark ...........................................................................................37
Bruno Hansen
1.3. France ...............................................................................................46
Daniel Thomas
1.4. The Federal Republic of Germany ...................................................53
Helmut Zeittrager
1.5. Greece ..............................................................................................68
Presentations by Drs Tzotzos and Dourtouglou
Karl Simpson
2.1. Argentina ....................................................................................... 136
José La Torre and Sara B. de Rietti
2.2. Brazil ............................................................................................. 145
Antonio Paes de Carvalho
2.3. Mexico ........................................................................................... 150
Rodolfo Quintero Ramirez and Rosa Luz Gonzalez Aguirre
2.4. The Andean Countries .................................................................. 171
B. Carlos Aguirre
Health in the Third World: The Role of International Co-operation .... 205
Luiz Pereira da Silva
Conclusions and Analysis ....................................................................... 211
Bernardo Sorj
1.6. The Republic of Ireland....................................................................73
Brendan Finucane and Staff of BioResearch Ireland, Dublin
1.7. Italy ..................................................................................................81
Carmello Iacobello
1.8. The Netherlands ...............................................................................90
Henk C. van der Plas
1.9. Portugal ..........................................................................................100
Julio Novais
I
II
PREFACE
The accession of Spain and Portugal to membership of the
European Community in January 1985 not only brought new vitality to the
European initiative, but served as a powerful reminder of the broader
dimensions of the Spanish – and Portuguese-speaking worlds. A
reinforcement of Europe’s natural and historical internationalism of
outlook was particularly relevant in the context of biotechnology; for the
sophisticated multi-disciplinary scientific base, and the several broad
application areas, force on biotechnology an internationalism both for
access to scientific capability, and for access to worldwide markets.
interests. Although inevitably any book on biotechnology is obsolete by the
time it appears, there is nothing obsolescent about the dynamism now being
displayed in the development of the bioindustries in both continents. We hope
that the presentations assembled in this volume will testify to this dynamic
development, and stimulate its further promotion.
The Editors,
Bernardo Sorj
Mark Cantley
Karl Simpson
Such was the rationale for SOBELA’: a Seminar on Biotechnology in
Europe and Latin America’, which in April 1987 brought some 50 Latin
American entrepreneurs, policy-makers and academic leaders to Europe and
to Brussels. At the Commission’s Borschette Conference Centre, they heard
presentations from eleven of the Community Member States, each
emphasising its strengths in biotechnology and its interest in promoting
industrial collaboration with firms in Latin America.
The seminar was opened by speeches from Vice-President KarlHeinz Narjes on behalf of the Commission, and by His Excellency Luis
Ramiro Alfonsin of Argentina, senior Latin American diplomat in Brussels.
In the closing session, Directors-General Paolo Fasella (Science, Research
and Development, DG XII) and Jean Durieux (External Relations, DG I)
welcomed Their Excellencies the ambassadors from Argentina, Mexico,
Brazil, Uruguay and Colombia.
The conference itself was preceded and followed by visits to the leading
centers in the various Member States. The fruits of these exchanges were
shown through more than a hundred proposals for industrial collaboration
which resulted, many of them now converted into ongoing relationships. The
Commission through its Directorate-General for External Relations is
continuing to promote such collaboration, helping firms in each continent to
find useful partners for trade, investment, technical collaboration or marketing.
The materials presented at the conference have been updated and
edited, to give in this book an up-to-date picture of capabilities and common
III
IV
transnational cooperation in research, and through training grants for
researchers moving to laboratories outside their home country.
WELCOMING SPEECH
Karl-Heinz Narjes
Draft text of a speech by Vice-President Karl-Heinz Narjes, on 27 April
1987, at the opening session of the ‘Seminar on Biotechnology in Europe
and Latin America’, Conference Centre Albert Borschette, Brussels.
Your Excellency, Mr. Chairman, Ladies and Gentlemen,
It gives me great pleasure to welcome, on behalf of the Commission,
the many distinguished visitors who have kindly accepted our invitation to
this international gathering. There are present, representatives of some
twenty different nations; but let me emphasise not our diversity, but our
common interests. The European Community and its Member States have
worked together to organise this seminar, and to offer to our guests from
Latin America our hospitality; our friendship; our ideas; and our hopes for
continuing and mutually beneficial collaboration.
The subject on which our common interests will be focussed during
this three-day seminar is biotechnology. Much can be said, much will be said,
during these three busy days; but even if we talk all day, we shall not exhaust
the range of topics covered by this broad subject. I speak with some
confidence on this; the Commission has been talking about biotechnology,
and developing its policies, for over ten years; some of our Member States for
much longer. Whether we adopt a narrow or a broad definition, we have to
recognise that ultimately the biological revolutions in progress will influence
or transform every field of application of the life sciences – including
agriculture and forestry, health care and pharmaceuticals, organic waste and
water recycling, and the care of the environment.
Initially, we saw biotechnology mainly as a research matter. Our first
programme, the biomolecular engineering programme, ran from nineteen
eighty-two to nineteen eighty-six, and was limited to the agriculture and agrofood fields. It sought to remove obstacles to the transfer into practice of the
advances in biological research. It was successful not only in scientific terms,
but in catalysing trans-frontier collaboration within our community, through
1
Our current biotechnology research action programme runs until
nineteen eighty-nine. It covers a wider range of subjects, including topics of
importance to all the bioindustries, both in research, and in improving the
infrastructure for research. We expect to expand the programme further in
the near future. You will probably hear more about these activities during
the course of the seminar.
I should mention also that the breadth of biotechnology inevitably
involves several other research areas, such as our agricultural research, our
medical research, and (of particular relevance to this seminar), our
programmes of science and technology for development. The first of these
programmes concerned tropical agriculture, health and nutrition. It ended in
December 1986; and we hope shortly to finalise a substantially larger effort
in the same areas, including a greater involvement of laboratories in
developing countries.
We also plan a major new biotechnology-based initiative to
stimulate innovative developments at the interfaces between industry and
agriculture. The industrialist, the farmer and the scientist must work
together to demonstrate and develop these innovations. This programme
will seek to develop:
New crops, better adapted to market needs in both food and nonfood applications;
New processes for cultivating and harvesting crops, for splitting
them into their constituent elements, and for transforming these
into higher value products;
New approaches to the control of pests and diseases, and to the
control of nutrition and metabolism in plants and animals. In this
or in other programmes, we shall be continuing research on the
assessment and management of any related risks.
But our policies for biotechnology in Europe go beyond research.
They interact with our plans for agricultural and industrial development,
for safeguarding the environment, and for developing harmonised
regulatory regimes in the Common Market. They include matters
2
ranging from price regimes for raw materials, to refinements of the laws
on patents and on plant variety protection.
In the context of this seminar, I want to emphasise the international,
indeed the global, dimensions of biotechnology. The techniques, products
and services of biotechnology are of central importance to countries rich
or poor, at every stage or their economic development. Here in Europe,
we believe we have major strengths and capabilities in biotechnology, and
we want to talk about these with you during the coming days. We are also
sure that we can learn from your experiences in your various countries. I
recognise that we shall have some differences of opinion – that makes it
all the more necessary to continue our dialogue, on occasions such as this,
and to understand the basis for our differences. But above all, we believe
that we have a common interest in learning together how to develop and
use biotechnology for your needs and ours, whether we speak of social
needs for health care and basic nutrition, or needs for commercial and
competitive developments.
Let me cite some practical examples. There is much fashionable
talk about the hypothetical risks of biotechnology. When we talk about the
needs for better vaccines, diagnostics and therapies, we are not talking
hypothetically, but about real, current and continuing disasters; about
hundreds of thousands of people round the world dying daily, to-day and
every day, from avoidable causes, from starvation and preventable
disease. We have the technology to produce the food; we have vaccines
and therapies for many of the diseases that are still killing people.
Through the methods of biotechnology, we have good prospects for
developing vaccines against major diseases not yet curable, for example
through our new ability to study the constituent parts of viruses, and to
manufacture in large quantities and high purity their antigenic proteins.
The development of monoclonal antibodies is providing precise and
effective diagnostic tools, and the basis for delivering drugs to precisely
targetted cells in the body. Such technologies are essential in the
continuing battle against parasitic diseases such as Chagas’ or to combat
the continuing and ever-changing challenges of malaria. They are equally
needed to confront novel challenges such as the AIDS virus. The major
risk to be avoided is the risk of unnecessary delay.
3
Concern is sometimes expressed about the impact of biotechnology
on the environment. Around the world, some two hundred million people
are engaged in ‘slash and burn’ agriculture. Of course, they are driven by
their local necessities; but by their actions, they are destroying the
remaining areas of tropical forest, with a loss of species estimated at several
hundred per day. We are likely to lose half of all current species within
twenty years; it is an environmental catastrophe, a species extinction of a
magnitude unparalleled since the death of the dinosaurs. It is not
hypothetical; it is happening now. Yet biotechnology can offer the means to
feed the world’s whole population more than adequately, using far less land
than we cultivate today. Further major gains in agricultural productivity are
now seen to be possible. By pursuing these, we should be able to take the
pressure off the environmentally sensitive areas, such as the uplands and the
wetlands, the unique ecological habitats. We should be able to defend our
forest, be it in temperate or in tropical zones, and restore our environment,
replanting appropriate species in degraded areas such as, here in Europe,
parts of our Mediterranean littoral.
I do not want to be simplistic about the practical difficulties which
inhibit the application of the new technologies to the problems of health care,
agriculture and environment. The political and economic difficulties are often
greater than those of science and technology. And above all, the application
of new science demands adaptation to local conditions, and integration with
local knowledge. Therefore collaboration and dialogue are essential, and our
joint learning will inevitably have to proceed through trial and error.
To put biotechnology to work requires men of action, bringing
together managerial abilities, local knowledge, capital and science, and
there must be a functioning system of trade. The successful application of
biotechnology depends on appropriate exchanges, not only of the ideas and
results of R&D, but also of the capital investment and trade in goods and
services which follow from the success of such research. There is no
alternative to progress in the liberalisation of world trade. The policy of the
European Community, which is the largest trading bloc in the world, is to
work seriously for the improvement of the current conditions of world
trade, through the GATT framework. For we know, not least from our own
experience within Europe, from Germany’s Zoll Verein in the nineteenth
century to our community of to-day, that trade is a ‘non-zero-sum’ game, in
4
which all players can win. But this policy has to be accompanied by
adequate measures in the same direction by the other important trading
countries. We are happy to see the corresponding bilateral and multi-lateral
agreements developing between countries within Latin America, and
between Latin America and Europe. These developments provide the
context within which biotechnology can thrive, encouraged by the prospect
of global market opportunities, and driven by the social and economic
needs to which biotechnology is relevant.
A subject which must raise, in connection with world trading
conditions, is that of intellectual property. As our world economy evolves
more and more towards knowledge-based industries, an effective
international system of respect for intellectual property is increasingly
essential. It is a mistake to see patents or plant variety rights as systems
defending the rich against the poor. Many biotechnology innovations may
be realised by small enterprises. In order to encourage innovation, it is
essential to provide adequate protection; and such protection facilitates
technology transfer, where secrecy would inhibit it. As our biological
science advances, the principles of protection for innovation are just as
applicable to plants, foods and medicines as they have been to electrical or
mechanical devices.
Member States the final details of our overall R&D programme, in which
biotechnology is a major element.
So if science and politics are playing their part well, they provide to
the businessmen, the entrepreneurs, the means and the possibilities for
innovation, investment and hence economic development. I hope that many
contacts will be made at this seminar, and that seeds of awareness will be
sown in these three days and in your visits to our Member States. We
must develop greater awareness of one another’s needs and capabilities,
and hence build co-operative and continuing relationships, which will
help us to develop and to share our advances in biotechnology and to
apply them to the achievement of our social and economic objectives.
We understand the strong desire of developing countries – indeed, of
all countries – to have effective control of science and technology. But if
we wish to enjoy the full benefits of science and technology, activities
which are as international in their sources as in their applications, then we
have to accept the fact of growing international exchanges. Recent
historical experiences show that escape from economic and technological
dependence is not through isolationism, but by increasing participation
through new creative models of involvement of worldwide developments
and consequent interdependence. The need again is to work together to
define fair conditions for such interdependence.
The scientists have delivered the goods, in terms of basic advances in
understanding and techniques. In Europe, we have recognised their
importance in the amendments to the treaty which are coming into effect:
the Single Europe Act gives an explicit legal base for our science,
technology and development activities. We have been debating with our
5
6
REMARKS
Phili Viehoff
Remarks by Ms. Phili Viehoff, Member of the European Parliament and
Rapporteur on Biotechnology for the Committee on Energy, Research and
Technology, at the opening of the second day’s proceedings, Tuesday 28
April 1987.
Ladies and Gentlemen,
Developments in biotechnology have been looked at on a number of
occasions in recent years by the European Parliament. In the past, it was
mainly the Committee on Energy, Research and Technology which was
responsible for drawing up reports, but for my last report, entitled
‘Biotechnology in Europe and the need for an integrated policy’, adopted in
February by the European Parliament, a number of parliamentary
committees were asked to deliver opinions; making specific policy
recommendations for the medium and long term.
It is not easy to enact laws on fundamental issues of complex nature
like, for instance, biotechnology. In many instances it implies a high degree
of confidence in the assessment and monitoring of the long-term implications
and consequences of the decisions taken today.
This is not yet the case! The decisions taken today do have more than
ever in the past far-reaching consequences for millions of people, whose
daily life will be deeply affected in the future. In a modern representative
democracy, it is a must that Parliament has the capability to legislate on the
basis of honest attempts to forecast and assess the long-term implications
and consequences of a given development; so that it is possible to monitor
and direct the processes in such a way that the impact is for the benefit of
mankind, not to its detriment. Since it has become clear that developments
in biotechnology have an international-character, international cooperation,
regulations and legislation are of great importance. Especially regulations in
the field of deliberate release of manipulated micro-organisms, because
they are not at all controlled by national borders.
Important is also the democratization of the decision-making process.
This means that more attention should be paid to the provision of balanced
information to the public at large in order to increase public awareness.
I found it of utmost importance that this multidisciplinary
technology, with such a wide range of applications was discussed not only
in the Committee for Energy, Research and Technology. Now that the
results of biotechnology research are rapidly finding their way into
commercial applications in many sectors of industry, agriculture and health
care, with far-reaching consequences, it is important to consider the various
policy aspects more closely.
I want to underline the fact that in a representative democracy,
Parliaments, before users of future-oriented research work, are amongst the
makers of the future. This is important to mention, because there is an
increasing tendency in several European countries to forget or minimize the
role of Parliament in advanced societies. The real decisions are too often
taken by powerful interest groups.
It is true that Parliaments are facing increasing difficulties to play
their role to its full and legitimate scope in a more and more complex and
fast changing society.
7
8
Why SOBELA?
INTRODUCTION
Karl Simpson
The Seminar on Biotechnology in Europe and Latin America
(SOBELA) took place in Brussels, 27-29 April 1987. Unlike many recent
meetings in biotechnology this was not an opportunity to display the latest
developments, but more importantly a chance to exchange information and
prepare commercial agreements based on the transfer of skills and
technology in the biosciences.
The meeting opened with important statements of interest and
goodwill by key scientific and political figures from Europe and Latin
America. Later, businessmen and scientists from the two sides of the
Atlantic described the infrastructures that support biotechnology activities
in their respective regions. It emerged that there was real scope for two way
exchange of skills, materials and equipment.
The Commission of the European Communities, CEC, and various
multinational groupings in Latin America were able to compare and
contrast the effectiveness of their enabling programmes. In both areas
regulation and legislation raise barriers to the free exchange of skills and
commodities resulting from biotechnology. In both areas collaborative
ventures are breaking down such barriers, albeit too slowly. Both areas
perceive the greatest competitive challenges to their biotechnology
industries to come from the USA and Japan.
Since April 1987 the stock market has become a less than safe
investment and the US dollar is no longer a safe alternative to gold. These
developments will have long lasting effects on the ease of raising capital
and the success of exported products from Latin America. More pressure
will be applied to Latin American governments to provide the means to
enable the development of an internationally competitive industry.
European biotechnology has moved rapidly from the position described in
‘Industrial Biotechnology in Europe’, edited by Duncan Davies, (CEPS, CEE,
1986) in which Europe was perceived to be failing to compete. In the past
year there has been a flurry of supportive and concertation measures at both
national and Community levels.
9
Europe and Latin America have social, cultural and linguistic ties,
which for many years have supported significant commercial exchanges.
The European Community is Latin America’s second biggest trading
partner (after the USA) and the biggest supplier of development aid.
The present problems of the Latin American economies lead many
Europeans to ignore the wealth of natural resources and the size of potential
markets. The good educational infrastructure and the presence of modern
technology and science-based industry offer considerable scope for mutually
profitable exchanges in the area of biotechnology. Despite sometimes being
included amongst the nations of the ‘Third World’, Latin America has made
significant contributions to developments in biotechnology and may have
acted as a stimulus to action in European biotechnology.
Existing training schemes funded by the European Community and
its Member States do much to enable skilled management and senior
scientific personnel to keep ahead of the latest technological developments.
Biotechnology also depends on the availability of highly skilled technicians
for whom fewer international training programmes are accessible. The
absence of such personnel is a serious hindrance to the development of the
biotechnology industry in Latin America. SOBELA participants meeting at
informal events had the opportunity to discuss, without commitment, the
nature of potential collaborations in this and other areas of interest to the
biotechnology industry.
In the absence of a formal biotechnology link between the European
Community and Latin America, SOBELA provided a forum for dialogue. The
presentations, summarised in the following pages, presented existing national
initiatives in industry and in the public sector. It will be immediately
noticeable that this was not a scientific seminar, but more importantly
perhaps, an overture for collaboration in industry and the underlying science,
mediated by diplomatic goodwill and influence. How can European/Latin
American collaboration in biotechnology serve national priorities?
The example of Brazil’s ambitious Gasohol programme so impressed
France’s President Giscard d’Estaing during his 1977 visit, that he
commissioned a report on French options in biotechnology. The report,
Sciences de la Vie et Societé’ by Gros, Jacob and Royer (1979) initiated the
10
chain of events that lead to the first ‘Programme Mobilisateur’, designed to
establish France as a leading contributor to the new technology, and
participant in the markets of the emerging ‘bioindustries’.
The United Kingdom and other European states in turn began the
implementation of hastily contrived programmes, designed to salvage
national position or pride in an emergent industry that seemed once again
destined to be dominated by the USA and Japan.
The example cited may in one case have acted as a spur to
development in Europe, but in general the direction of technology transfer is
predominantly in the opposite sense. What can Europe and Latin America do
for each other? What are the perceived needs of these two widely different
groups of nations? Firstly we shall examine what we mean by biotechnology.
The Scope of Biotechnology
Very broadly, biotechnology may be defined as the purposeful
application of biological science, thus encapsulating most aspects of current
and traditional agriculture, food production and health care, narrower
definitions of phrases such as ‘new biotechnology’, forms specifically upon
the more prominent modern techniques of genetic engineering, monoclonal
antibodies, and their applications.
Biotechnology has a prehistory, which predates the keeping of
records or experimental details. Into this area must fall the first examples of
cheesemaking, beer and wine manufacture and some aspects of traditional
medicine. The transition from tradition to science took place around the end
of the 18th century. At about that time the scientific method was becoming
respected, the microscope was becoming a serious research instrument and
the value of careful measurement was becoming realised. The quantitative
approach saw fruits in the researches of Mendel and the flowering of
organic chemistry, although a century was to pass before those disparate
strands could be drawn together in the new biology.
Until the second world war many basic organic chemicals were made
by fermentation and subsequent purification. Glycerol, acetic acid, citric
acid and many other solvents and acids were extracted from stirred tank
fermenters using molasses as a raw material. In Japan monosodium
11
glutamate production from strains of aspergillus was the first pure product
of the fermentation industry, other than alcohol.
Microbiological development in the same period had been rapid as
had the growth of medical genetics, but perhaps the most critical discovery
for modern biotechnology was the discovery of penicillin action by Fleming
in 1928. The stimulus of the second world war created a need for the large
scale production of antibiotics. Because of the development of several
different strands of appropriate technology it became possible to achieve
the growth of moulds and filamentous bacteria in highly defined and
controlled conditions. In 1940 Florey and Chain succeeded in isolating and
purifying penicillin in a manner which allowed mass production. The
development of downstream processing can be traced to this period.
The perfection of the hybridoma technique for the production of
monoclonal antibodies resulted from the work of an Argentine scientist
carried out in a British laboratory. César Milstein with Georges Köhler
went on to share the Nobel prize.
In Latin America it is possible to say that much large scale use of
biotechnology remains at roughly the stage reached in Europe by 1945. There
are relatively sophisticated brewing and food technologies and increasingly a
degree of competence in medical technologies such as vaccine manufacture.
The inclusion of state of the art skills will hopefully be one of the results of
some of the ambitious programmes described in this presentation.
There is a real danger that biotechnology is being presented as a new
industry. This is quite clearly not the case. Biotechnology is a set of
enabling technologies which will find application in the existing
bioindustries, i.e. the several sectors of activity based upon the applications
of life sciences and/or the use of materials of organic origin. It is quite fair
to say that some aspects of biotechnology have allowed the launch of new
companies such as Genentech or Celltech, which rely exclusively on the
new technology for their sales. The outlets for their products quite clearly
label those companies as newcomers in the pharmaceutical industry, rather
than harbingers of a completely new industrial sector.
Modern biotechnology has the potential to change profoundly the
nature of several major industrial sectors. This potential has as its
foundations two very different sets of skills. Firstly, there exists an
12
assemblage of biological and engineering skills built up over centuries of
experience in the fermentation industry. Secondly, and in the public eye,
more prominently, modern molecular biology has allowed the tailoring of
genomic material and cells to serve specific goals. The first biotechnology
revolution occurred, not in the 1970s, but in the 1940s when the industrial
scale production of antibiotics necessitated radically new developments in
fermentation technology and downstream processing.
In the course of the Seminar Professor Da Silva, working in Paris at
the Pasteur Institute, used the example of vaccine production to identify
four generations of biotechnology.
Generation
Fist
Second
Third
Fourth
Vaccine Type
Traditional
Polio, Mumps, Rabies
Hepatitis
AIDS?
Technology used
Eggs/in vivo extract
Cell culture isolation of virus
Genetic manipulation
DNA/Peptide synthesis
Europe is currently experimenting with Fourth Generation vaccine
production, while Latin America is locked into the Second Generation. Can
it become economically justifiable for Latin America to acquire its own
Third and Fourth Generation capacity?
From the viewpoint of a commercial entrepreneur, biotechnology
serves to make money from biology. Growing public concern for the
environment and public health risks, has in some cases limited the application
of biotechnology. Such issues as the erosion of the earth’s ozone layer and
CO2 build up in the atmosphere have sensitized the public to possible harmful
effects of scientific and technological innovation. It is to the credit of the
biotechnology industry in Europe and North America that their own policing
standards have disarmed most critics. Biotechnology has succeeded in
building up an environmentally responsible image, although as Mrs Viehoff
emphasised, there is no room for complacency. The environmental record of
the Latin American bioindustry will come under dose scrutiny if its products
are to be launched on the European market.
Like any innovative industrial activity, biotechnology is underpinned
by an investment in Research and Development, R&D. The R&D financing
comes either from the private sector, the public sector or a mixture of both.
In the following chapters specific examples of European and Latin
13
American experiences will be presented, however certain general principles
can be outlined here. Industry is concerned with making money in the
medium or short term. R&D in biotechnology is very expensive and in
industrial laboratories must be aimed at process improvement or product
development, linked to astute market analysis if profits and long term
success are to be achieved. In the case of modern genetics, applied
industrial research is supported by the results of public sector research,
published in open sources.
To take a very obvious example. The structure of DNA, resolved by
Watson and Crick in 1953, underpins the whole of modern molecular biology,
which is one of the foundation stones of biotechnology. The discovery of DNA
structure was made possible by public sector funding. The synthesis of human
insulin by a yeast or bacteria would be unthinkable without knowledge of DNA
structure. Human insulin is sold by many reputable companies, who could not
dream of financing a research programme that might give commercial results
only after 25 years. Yet it was only in 1988 that the first genetically engineered
insulins appeared on the market.
The European Commission has been deeply involved in discussions
about the nature of fundamental research, precompetitive applied research
and competitive industrial research, as applied to the biotechnology area.
Fundamental research in Europe has historically been a matter for national
funding programmes, while competitive research is quite properly the domain
of industry. The middle ground is a difficult area in which all available
goodwill must be coordinated so as to realise public sector/private sector
collaboration. In Latin America collaboration in the Andean Pact states and
between Argentina and Brazil is tackling specific goals perceived to be of
regional benefit. The European Commission has attempted to tackle this
middle ground through the Biotechnology Action Programme, BAP, which
will be described later. Future European Community programmes will
concentrate on providing enabling technology for the European bioindustry in
order to enhance international competitiveness. The nature of European/Latin
American collaborations may depend to some extent on the willingness to
compromise such competitiveness in relations with the Latin American states.
Ten years ago very few firms could think of a commercially
justifiable reason for having molecular geneticists on their staffs. It would
now be considered foolhardy for a European pharmaceutical company not
14
to employ such people. Later on, contributors to this volume will show why
this is not always the case in Latin America.
At present the agricultural industry is waking up to the promise of
biotechnology. In ten years it will be unthinkable for a major seed supplier
not to have a molecular genetics team. Dr Sargeant, working in the European
Commission, showed that it is likely that the very nature of agriculture and
land use may be changed by developments made possible by
biotechnological research. Such consequences might be of more immediate
relevance to agriculture in the developing world, including Latin America.
In Western Europe, the United States and Japan, the main thrust of
recent industrial activity in biotechnology has been orientated to the
production of therapeutic products and diagnostics, both in the health
sector. The public perception of biotechnology has been strongly influenced
by issues as diverse as AIDS, the recent availability of highly publicised new
wonder drugs, thrombolytic agents for heart attack victims and the dramatic
application through forensic science of ‘genetic fingerprinting’.
What can Biotechnology Offer?
The first impact of biotechnology has been in the area of human
health. The public has seen remarkable progress made in the treatment of
viral diseases and cancer, using the twin technologies of molecular genetics
and cell fusion. Molecular genetics gave rise to genetic manipulation and
cell fusion gave rise to the ‘magic bullets’ of monoclonal antibodies.
Products resulting from DNA cloning and expression in microorganisms include: insulin, lymphokines, clotting factors and thrombolytic
agents. Monoclonal antibodies have been the basis for simplified diagnostic
tests and the hope of a cure for several cancers. Monoclonal antibodies can
be used as guided missiles, carrying a ‘warhead’ of toxin or radioactive
element to a specific target, such as the cells of a malignant tumour.
There is a great deal more to biotechnology than the health care
sector. As a set of technologies it is poised to offer benefits to a number of
industrial sectors including: Food, Environment, Agriculture and Animal
Health, Chemicals, Mining, Energy and, of course, Human Health.
Despite the conspicuous successes of some health care applications,
some goals have proved unexpectedly difficult to realise. Plant
15
biotechnology, for long the Cinderella of the biosciences is hastily
constructing a carriage to get to the ball! Despite the early delays, the pace
of discovery in this area is now remarkable.
The prospects of controlled nitrogen fixation by incorporating the
genes of bacteria into flowering plants have proved difficult to realise. The
complexity of the problem was underestimated by the naively phrased
publicity which portrayed molecular biology as a universal solution in
search of problems to attack. The hopes for alcohol from wood have also
evaporated as enzymatic means of lignocellulose degradation have proved
impracticable as a commercial process. Responsible scientists had always
pointed out the difficulties involved, but the media, conditioned to a science
which realised the impossible, would not accept such stark realism.
Political pressures are also significant. Debate has raged on the
introduction of an EEC sponsored bio-alcohol programme, portrayed as an
alternative to adding lead to petrol. Backed by several agricultural and
fermentation companies, but strongly opposed by producers of industrial
alcohol and more cost-effective lead substitutes, the ultimate decision looks
set to be made as much on political grounds as on economic: finally, the
argument was resolved by the decline in the price of oil and the
strengthened Community commitment to budget discipline.
The Latin American countries with their vast genetic resources could
well harbour microbiological resources that might offer solutions to some
industrial process problems. Screening and identification of natural resources
is an aspect of biotechnology that is often overlooked in Europe and North
America. The potential reward in terms of useful biological activities is
immense. Microbial screening using fairly traditional technologies is a key
area in which Latin America can make a contribution to European
biotechnology. A recent expedition to Brazil by staff of the Cranfield Institute
of Technology, UK, underlined the importance of resources held in
developing countries. The expedition hoped to collect samples from the
Amazonian forest, with a view to understanding the rapid turnover of
vegetable life on a very thin topsoil. Genes locked in Amazonian organisms
could play an important role in the energy and environmental industries in
years to come. Obvious applications in the environment sector include
sewage treatment. The growing problem of urban sprawl in the developing
world, makes sewage control a major issue in environment and public health.
16
Mining has received comparatively little attention from the public,
but micro-organisms have been developed that are capable of concentrating
minerals of commercial value from normally unworkable deposits. The
same techniques could scavenge environmentally dangerous elements such
as Cadmium or Mercury.
Biotechnology can do more than exploit existing markets. As old
markets are eroded biotechnology has the potential to create new markets
and revenues. In the context of SOBELA we must address the question of
how biotechnology can serve the common interests of Latin America and
Europe. Cynics will find it easy to say that major European companies will
exploit Latin America. Collaboration should be approached with caution so
as to distribute the benefits equitably between partners. The contributions of
the following chapters show that indeed we do have something to learn
from each other in terms both of science and models of cooperation.
European Biotechnology
Most European states have taken action at government level to
improve competitiveness in the area of biotechnology. National programmes
and coordinating bodies have until recently had little interchange of views.
Even the European Commission has had comparatively little success in
coordinating national strategies in biotechnology. Despite thirty years of
community it is not generally appreciated among European governments, to
what extent the European Commission works on their behalf in the
harmonisation of regulations and the elimination of barriers to trade and free
movement of personnel and skills. The probable impact of the 1992 target
date for the removal of internal barriers to trade is gradually being
appreciated by European industrialists, thanks to an information campaign
orchestrated at national levels.
Total public sector biotechnology spending in the EEC member states
may not be far short of that spent in the USA – estimated at $2.7 billion in
1987 by a report from the Congressional Office of Technology Assessment.
Partly because of duplication and fragmentation of effort and largely
because of differences of commercial opportunism and the absence of a real
Common Market, Europe nonetheless lags behind both the USA and Japan
in the commercial exploitation of biotechnology.
17
The funding of new ventures has been easier in the USA than in
Europe. Seedcorn capital, venture capital, tax concessions and the
entrepreneurial tradition are particularly North American attributes. Europe
however has less often had to write off investments in failed ventures. The
most conspicuous examples of failure in Europe have involved US
companies operating without a tightly defined business plan. In the past two
years European entrepreneurs have established a substantial pool of venture
capital, with several specialist funds able to evaluate ventures in
biotechnology. The United Kingdom has Europe’s most sophisticated venture
capital market, modelled on the USA, but characterised also by European
conservatism. Some analysts now say that there are more new funds in
Europe than the USA, although the pool of American funds, especially in the
area of seedcorn capital will continue to be larger for the foreseeable future.
Europe probably has much to offer Latin America by way of advice
on business start up schemes. If this can be integrated with some of the
existing programmes and experience, it may be possible to fund suitably
targeted biotechnology start-ups in Latin America.
In Europe two very different types of company have played a role
in the new biotechnology. In the first instance medium to large
companies, with diverse products and a long established tradition in
product sectors ranging from engineering and chemicals to ethical
products, have adopted the new technologies as a logical extension to
their portfolios. More recently a second kind of company has emerged,
backed by risk capital, small to medium sized, with a very few but very
high technology products. Whereas in the USA such small companies
dominate the biotechnology sector, in Europe it is the old, traditional,
medium to large companies that dominate.
The larger companies in Europe, such as Elf-Aquitaine, Hoechst, ICI,
Unilever etc. have added rDNA technology to their research programmes in
health care and agriculture. In the UK and Netherlands university/industry
partnership has played a major role in transferring appropriate technologies.
Many of the resulting small firms, which succeed by attracting investment,
become in turn targets for acquisition by the larger companies with a more
conservative approach to new technology. Large companies are often
unwilling to gamble on untested technology, but happy to pay the going
price for proven products.
18
Even for the largest companies the regulatory and legislative barriers
that exist in Europe are a major headache. A large company will have a
regulatory affairs department far larger and more expensive than a USA
company of the same size that focuses only on the internal USA market.
Latin American Biotechnology
In Latin America as in Europe, manufacturers of ethical products
have had to face a number of different regulatory regimes. The cost of
overcoming different national requirements has proved prohibitive for
many smaller companies. In Europe as in Latin America, multi-national
negotiations are moving ahead with the desire to provide a unified
regulatory system. SOBELA might prove a launch point for European/Latin
American negotiations in this area.
The SOBELA meeting demonstrated the steps taken by Latin
American countries to rationalise, regroup and pool skills in this
important area of high technology. Biotechnology has been the focus of
an almost unprecedented dialogue between the Latin American states.
Typical results of this dialogue include Argentinean/ Brazil collaborations,
Andean Pact collaborations and an increasing Mexican involvement in
South American biotechnology.
The SOBELA Meeting
Introductions by several distinguished speakers confirmed the extent
of goodwill among the participating states. The subsequent presentations
gave an overview of the status of biotechnology in Europe and Latin
America. Speakers from both sides of the Atlantic affirmed their
governments’ commitments to collaboration and several presenters were
able to speak of specific examples.
Dr Pereira da Silva explained that biotechnology cannot be regarded
as a panacea for the problems of a developing economy, although its
application to well defined problems could yield very significant benefits.
Many of his recommendations could be summarised by saying that what
Latin America, and other developing countries, need is the establishment of
bilateral accords with developed nations which permit training and the
creation of a domestic infrastructure capable of supporting the benefits to be
wrought by biotechnology.
The following chapters consider the state of biotechnology in
Europe and Latin America. To what extent are the goals of collaboration
likely to bring tangible benefits to participants?
Whereas there are a number of interesting biotechnology start-ups
funded by private or state organisations, it is notable that the local market is
already being assaulted by the established multinationals. Many middle
sized European, Japanese and N American firms are establishing marketing
structures in Latin America. Several are contemplating the establishment of
manufacturing and R&D facilities. These companies in particular must be
encouraged to enter into a constructive dialogue with the nascent domestic
biotechnology companies. This route might also be the most appropriate if
European companies are to avoid the pitfalls of inadequate patent
protection. It is difficult for companies to defend their intellectual property
rights if they are far away from the market or competition concerned – even
where such protection is legally guaranteed. Several small European
companies have lacked the financial resources to defend infringements of
their intellectual property rights in the USA.
19
20
SECTION ONE
1.0. OVERVIEW OF EUROPEAN ACTIVITIES IN BIOTECHNOLOGY
BIOTECHNOLOGY IN EUROPE
Karl Simpson
European administrations and industrial organisations have realised
that they cannot afford to miss out on the exploitation of biotechnology.
European scientists working in industrial and university laboratories have
made decisive contributions to the methodology of this ‘New
Biotechnology’. The first University Chair in biotechnology was
established in Lyngby, Denmark in 1905 and the world enzymes market is
dominated by two European companies; Novo, Denmark and GistBrocades, Netherlands.
Although total European industrial spending on biotechnology is
approaching that of the USA, it is in the USA and increasingly Japan, that
new commercial opportunities are being exploited. The funding of new
ventures has been far more difficult in Europe. The USA offers important
tax concessions for new ventures and there is ready availability of seedcorn
and venture capital. Perhaps most importantly the USA has an
entrepreneurial tradition that respects the risk taker.
The most important disadvantages facing Europe are those of internal
language and trade barriers. Despite the activities of the European Commission
there are still separate markets in the European Community, with different
regulatory practices, legislatures and languages. rDNA regulations vary widely
in the community. In Denmark draconian legislation is driving R&D out of the
country to more hospitable locations. The same may soon happen in Germany
where a strong, but uninformed Green movement has considerable influence.
Surveys have revealed that opposition to rDNA is most deeply rooted where the
public perceives itself to be uninformed.
The harmonisation of Community regulations, aimed at creating a
single market ready for January 1st 1993, is expected to improve this state
of affairs, although much work will have to be done. The European
Community has adopted a number of research and training programmes to
stimulate and strengthen biotechnology in Europe. Proposals from the
Commission from the mid-1970s were finally adopted by the Member States
in 1981, launching the Biomolecular Engineering Programme, SEP’: 15
MECU, 1982-86. This addressed specific bottlenecks, applying the results of
21
22
modern genetics and enzymology in the agro-food sector. The larger
Biotechnology Action Programme, ‘BAP’: 75 MECU, 1985-89, embraced a
wider range of biotechnology topics, including topics of interest to a wider
range of industries, an expanded safety programme, and projects on
‘infrastructure’ to strengthen cell- and micro-organism collections and
databanks. At the time of going to press, a 100 MECU programme,
Biotechnology Research and Innovation for Development and Growth in
Europe, ‘BRIDGE’, 1990-94 is before Council and Parliament.
In addition to the research and training programmes, the Commission
has recognised since 1983 the value of a coherent strategy for biotechnology,
embracing not only the programmes mentioned above, but five other action
priorities:
new regimes for sugar and starch, to make these raw materials
available at a competitive price to Community industry;
new regulations, to provide in the context of the developing
Common Market a common regulatory framework for
biotechnology and its products;
new regulations for the protection of intellectual property (patents
and plant varieties), to ensure in the field of biotechnology clarity
of legislation and adequate protection to maintain the incentive for
research and innovation;
demonstration projects, to stimulate the transfer of new
technology towards commercialisation, in particular across the
intersectoral and inter-disciplinary boundaries between science,
industry and agriculture. The 80 MECU European Collaborative
Linkage of Agriculture and Industry through Research, ‘ECLAIR’,
was a result launched in 1989;
a ‘concertation’ action, for monitoring and awareness of emerging
opportunities and challenges, and in order to improve co-ordination
in biotechnology relevant policies between the several Commission
services involved, and between Community and Member States.
With the strong support of the European Parliament, this multidimensional response enabled the Commission to develop an
integrated response to the challenges of biotechnology.
23
One of the most desirable consequences of Community and National
activities in biotechnology has been the move to enhance communication
between nations, industry, universities and ministries. Inter-national
consultation has been a feature of newly established biotechnology
programmes such as those of Greece and Spain.
The European Biotechnology Industry
In the USA the biotechnology industry is dominated by small high
tech companies with few products, brought into existence with venture
funding. In Europe medium to large companies with a long established
pedigree and a diverse range of products from fertilisers to DNA probes are
dominant. Until very recently only in the UK, and to a much lesser extent
the Netherlands, has venture capital allowed the emergence of significant
numbers of small to medium US style ventures. In 1988 and 1989 new
venture capital companies are seeking business in all parts of the
community. Significantly there is some real seed corn capital available.
All of Europe’s traditional chemical and pharmaceutical giants have
now invested heavily in rDNA technology, adding it to their mainstream
programmes in the health care and agriculture sectors. University/Industry
partnerships have played a major rle in transfer-ring the appropriate
technologies. In the UK this is typified by the ICI/University of Leicester
relationship. Leicester, where Alec Jeffreys invented DNA fingerprinting, is
one of Europe’s leading centres of rDNA research. In W Germany Hoechst
(still in disfavour with the government after its decision to invest in
Massachusetts General Hospital) has a number of collaborative ventures
with university laboratories.
What Are Europe’s Strengths?
The fragmentation of Europe has paradoxically provided a major asset.
Firms have grown up in an environment that requires export earnings.
Knowledge of export regulations and a lack of dependence upon internal
markets are in sharp contrast to many US firms who have the world’s largest
single market at their doorstep. The old colonial powers of Europe have left
their languages as a permanent monument to occupation. Language thus
provides privileged access to markets such as Latin America and Africa.
24
Several areas of biotechnology are dominated by European science or
companies including: enzyme production, agro-biotechnology, biosensors,
waste treatment and speciality chemicals.
European firms are generally willing to contemplate participation in
joint ventures, both within and outside the Community. There is some
apprehension about the loss of European proprietary knowledge to the USA
and Japan through mismanagement of joint venture activity.
A Summary of National Activities in the EEC
B ELGIUM
The governments of the Flemish and French speaking areas have
both implemented support programmes for biotechnology. Large companies
Solvay and Smith Kline Rit have moved firmly into biotech. Small
companies including Plant Genetic Systems and Phytotec, with good
university contacts are making rapid progress to success internationally.
DENMARK
Despite a tough attitude to biotech legislation, the government has
committed another US$60 million in the next four years. A small country,
but strong in enzymes and gene technology. Novo has been active in protein
engineering and European collaboration. Rationalisation in the domestic
biotechnology industry is exemplified by the merger of Novo and Nordisk,
both major insulin producers with rDNA technology.
FRANCE
In 1987 the conservative government overturned spending committed by
the departed socialists, but the biotechnology Mobilisation Programme
continued in weakened form. May 1988 saw the Socialists return under Rocard,
and Minister Curien almost immediately instituted massive new investment in
biotechnology. France has major strengths in bioreactors centred on Daniel
Thomas in the University of Compiègne. Agro biotechnology is another strong
field, Limagrain has developed artificial seeds and Moet-Hennessy is looking at
the micropropagation of woody plants. Club Agri has a 4 year, US$3 million
programme of club sponsored research.
Sanofi, an Elf Aquitaine subsidiary with major health-care biotech
commitments had turnover of more than US$600 million last year.
25
Transgène, the rDNA and cell biology firm works in collaboration with
several major French companies and is starting to be a candidate for entry
into the international league.
FEDERAL REPUBLIC OF GERMANY
One of Europe’s biggest biotech spenders. Major public expenditure
by both central (US$700 million over 5 years in latest programme) and
regional governments. Central government is being forced by Green
movement to enact restrictive legislation. Some companies may look
elsewhere for new R&D activity. Biotechnology Centre in Braunschweig is
world class for fermentation development and general biotech activity.
Companies such as Hoechst, Bayer, BASF have bought in all the new skills,
but are very secretive about R&D. Hoechst is far advanced in yeast
expression systems, but information about future products is mostly
rumour. BASF is the latest giant to earn government disapproval as it sites
its major molecular biology facility in the USA. The Bissendorf
Biotechnology Group have come from nowhere to being an exciting group
of companies with international connections and major investments.
Venture capital is opening up and a number of new firms are taking off.
Middle sized companies such as Biotest have gone public to fund new
biotech activities.
GREECE
Not really a biotech power, but the Institute for Molecular Biology
and Biotechnology, Heraklion, is a major new institute devoted to keeping
Greece in the picture. Vioryl is important in flavours, pheromones and plant
tissue culture. Biohellas is first biotech company to exploit new legislation
to create high tech enterprises. Old pharmaceutical companies such as PN
Gerolymatos are entering the area of biotechnology.
REPUBLIC OF IRELAND
Weak economy undermines the very strong university system which
offers top class skills. Small biotech companies have arisen to exploit
Ireland’s Import Substitution Programme. Guinness has major bio-tech
investment with top class rDNA facilities and skills in yeast biotech. The
Agricultural Institute in Dublin funds animal and plant biotech studies.
Several companies such as Biocon, Nochtec, are having success in exports.
26
ITALY
Has come rather late into the arena, but is putting money into a major
national initiative to support industry in a range of mission-orientated
projects. The government has talked of an Italian Human Genome project.
Major companies are in acquisition moods and have got hold of biotech
skills. Farmitalia, Ferruzzi and the ENI group (including Sclavo) are
leading firms. Major academic industrial collaboration is being encouraged.
T HE NETHERLANDS
Small country, but host to several multinationals. Biotechnology is of
great importance with 7% of world turnover. The government restructured
biology six years ago and most university research is now partly industry
sponsored. After uncomfortable start, applied research is stronger in
Netherlands than anywhere else in Europe. National skills include enzymes,
yeast, dairy biotech, protein engineering. Major companies include:
Unilever, Philips, Shell, Akzo, Gist-Brocades. Many small companies are
university or institute based and enjoy good relations with big brothers.
Government encourages foreign biotech investment.
pioneered access to venture capital, about half European venture funding in
biotech is British (although as much as 70% is invested in USA). Despite
cut-backs in fundamental research, applied research is receiving support
from the biotech programmes of several ministries. Giants like ICI,
Unilever, as well as smaller firms work with university departments.
Celltech is now in profit situation as world’s largest monoclonals
producer. It will be the first British start up to make the transition from
small high tech to tomorrow’s new style middle size pharmaceutical firm.
Although overall spending is limited the UK actually has competence in a
wider range of biotech activities than the USA. Strong points include
biosensors and protein engineering, PE. The Inmos transputers are being
assembled in parallel to give enormous real time power for PE applications
in the hands of companies like British Biotechnology, which in addition is
perhaps the only firm to offer routine gene synthesis. The UK has pioneered
the application of the ‘club’ concept for industry-university collaboration.
P ORTUGAL
Newly arrived in the EEC, Portugal has little biotech. A national
Biotechnology Centre is now proposed. Companies include: Cipan
(antibiotics) and Franco-Farmaceutica (immunology, vaccines). The 21
renowned Gulbenkian foundation is not interested in commercial spin off
operations.
SPAIN
Spain until recently had no significant biotechnology industry, although
it has first class university facilities. A major Mobilisation Programme is
intended to put Spain on the biotech map. Built at a cost of US$3 million the
new Biotechnology Centre with a British head, Dr Michael Parkhouse, will
house more than 100 scientists. Biotechnology active companies include:
Atom, Laboratoris Girfols, Laboratoris Knickerbocker and Processos
Enzimaticos. University/ industry collaboration is in its infancy.
UNITED K INGDOM
Government spending in biotech is lower than that of Germany, but
UK has arguably the most healthy biotech industry in Europe. UK firms
27
28
1.1. BELGIUM
Adapted from speech made by Mr C. de Wispelaere
In 1980 the state of Belgium agreed to a substantial devolution of
power to the two regions of French and Dutch speaking peoples. This move
was to have profound consequences on all aspects of Belgian
administration, including science and industrial policy.
National and Regional funds are administered separately, but despite
the potential for conflict, pragmatic administrators make the system work.
Biotechnology has long been regarded as a strategic technology,
and as such has received strong support from both state and regions. In
practical terms the regions have placed greater emphasis on industrial
biotechnology, while the state has emphasised fundamental or
precompetitive research and international collaboration programmes of
both academic and industrial nature.
The Role of the State
Belgium has a highly developed university system and a
distinguished record of achievement in the life sciences. In 1984 the state
made available funds of US$125 million for life science research of which
US$50 million was designated for biology and biotechnology.
Funds are administered by a number of bodies:
The Ministry of Education which funds the day to day running of
the universities.
• interuniversity attraction poles for high technology aim to
further increase the efficiency of university biotechnology by
‘networking’.
The National Fund for Scientific Research (NFWO IFURS) financed
by the Ministry of Education provides grants for research.
The Institute for the Encouragement of Scientific Research in
Industry and Agriculture (IWONL IIRSIA) is funded by the
Ministries of Economic Affairs and Agriculture. It provides grants
for applied research.
The Regional Authorities also allocate funds to university research
in biotechnology.
Some Prominent Research Groups in the Areas of Agriculture and
Medicine
AGRICULTURE
Professors Van Montagu and Schell from Rijksuniversiteit Gent are
active in plant molecular genetics and Agrobacterium.
Professor Briquet at the Université Catholique de Louvain is
renowned for his work on cytoplasmic male sterility.
Professors Bernier, Université de l’Etat à Liège, and Jacobs, Vrije
Universiteit Brussel, work in the area of molecular physiology of plants.
Professors Boxus and Semal, Faculté des Sciences Agronomiques de
Gembloux, are known for excellence in micropropagation.
MEDICINE AND HEALTH
The Belgian Science Policy Office which carries out three
different initiatives
Excellence is found in many centres. Those with broad based
competence include:
• concerted actions Centres of excellence are identified and
supported with grants over a six year period.
The Institute of Molecular and Cellular Pathology (ICP), associated
with the Catholic University of Louvain, was founded in 1975 by Nobel
laureate Christian de Duve.
• impulse programmes fund applied research tools such as
microbial culture collections and strategic studies aimed to
optimise the performance of Belgian biotechnology.
29
30
Professor Ghuysen’s group at the State University of Liège, which
studies the molecular basis of enzyme activity.
Professor Fiers at the University of Ghent elucidated the complete
primary structure of a gene in 1972. He is now active in the cloning and
expression of interferons and lymphokines.
Professor Collen of the Catholic University, Louvain isolated Tissue
Plasminogen Activator, TPA, currently at the focus of attention as a
treatment for heart attack and thrombosis.
Professor Martial’s group at Liège has studied the expression of
genes for prolactin, growth hormone and placental lactogen.
Many other excellent teams exist, suffice it to say that the quality of
precompetitive research in Belgium is high. Twenty six Belgian research
teams participate in the European Commission’s Biotechnology Action
Programme, BAP.
In the industrial sector, involvement in biotechnology is keen,
although Belgian firms are active predominantly in traditional
biotechnologies in the food, pharmaceutical and agricultural areas.
Involvement in the new biotechnologies of gene manipulation and advanced
bioprocessing is concentrated in the pharmaceutical industry, although
exceptions such as Plant Genetic Systems have achieved world renown.
Biotechnology in Flanders
The Institute of Molecular Biology, at the Free University of Brussels
(VUB/ULB) carries out basic research in prokaryote and eukaryote genetic
manipulation, developmental biology and immunology.
The REGA institute of the Catholic University of Louvain, founded by
Professor de Somer is a centre for applied research in medical microbiology
and immunology. Excellent work in lymphokines, cytokines and interferons
has been carried out.
Smaller centres of excellence include:
31
Flanders is the Flemish (or Dutch) speaking part of Belgium. Flemish
policy concentrates on the stimulation of contact between industrial and
institutional laboratories with a view to augmenting regional
competitiveness. Co-operation models such as Limited Research
Partnerships are implemented when appropriate.
Third Industrial Revolution in Flanders, DIRV, is the title of the
regional action plan for high technology, designed to stimulate businessmen
looking for new technologies and markets and foreign investors looking for
high tech locations for production sites. Biotechnology is identified as one
of the strategic technologies.
32
Nearly 60 companies in Flanders are in some way exploiting
biotechnology. The whole spectrum of biotechnological applications is
covered, but there is an emphasis on food and agricultural activities (2/3 of
Belgian agro-food companies are in Flanders).
Table 1. Companies in Flanders involved in applications of biotechnology.
Flanders
Belgium
Food industry
19
26
Diagnostics and therapeutics
7
31
Agriculture and horticulture
13
21
Environment
10
18
Chemistry
2
10
Aquaculture
1
2
Engineering
9
12
Total
60
120
Agro-food applications include refinements of traditional
fermentations of milk products, beer, bread, meat products and sugar.
Special emphasis has been placed on the development of diagnostics and
the production of biological substances. Two companies illustrate the
situation in Flanders:
Innogenetics was established in 1985 to develop and market diagnostic
and therapeutic products for the human and animal health care market using
recombinant DNA, cell culture, monoclonal antibodies and other advanced
biotechnologies. The company has its own R&D competence and a number of
collaborative ventures both in Belgium and abroad.
Biogent was established in 1982 as a division of Biogen US. It
operates in dose association with Professor Fiers at the Laboratory of
Molecular Biology. rDNA technology is used to develop products for cancer
treatment, immunological anomalies, viral infections, cardiovascular and
other diseases.
Biotechnology in Wallonia
the agriculturalists
value to starch and
The Walloon region (French speaking) has aimed to establish itself as
a pole of excellence, essentially orientated towards the outside world.
Several measures have been taken to expedite this aim:
Amylurn in Aalst is studying the fermentation of starch and sugars,
and with Plant Genetic Systems, PGS, participates in a Limited Research
Partnership on protein engineering of saccharide enzymes.
Direct support to universities for applied industrially orientated
research. Examples include development of a vaccine against swine
plague, development of antibiotics by protein engineering and the
improvement of plant species by in vitro culture.
CEBOBA is a research centre founded by
association, AVEVE and the Artois brewery. Adding
lignocellulose substrates is the focus of activity.
Plant Genetic Systems merits further attention as the ‘Jewel in the
Crown’ of Belgian biotechnology. Founded in 1982 as a joint venture
funded by: Tienen Sugar Refinery, Radar, Hilleshög (a Volvo subsidiary)
and the Regional Investment Company of Flanders. PGS has attracted
attention in the international press for its achievements in developing
herbicide resistant plants by gene manipulation. Further work includes new
developments in Plant Engineering, Microbial Engineering and Protein
Engineering. Close links with Professor Marc van Montagu in the
university of Gent and Professor Shoshana Wodak in the University of
Brussels assure excellence in genetics and computer aided protein design.
Medical Sector developments are underrepresented in Flanders with
only 25% of the Belgian biomedical companies. Those companies have
however been active in exploiting the advances of the regional universities.
33
Support to and co-operation with industry. Essentially to support
innovation for example by making available ‘Technology Innovation
Consultants’ (in French – Responsable d’Innovation Technologique) and
by funding sectorial analyses so as to tailor a competitive strategy. In
1982 the Walloon Regional Investment Company launched a holding
company, Companie de Dévelopment de l’Agro-industrie et des
Biotechnologies.
Intra and extraregional actions. Operation Athena is designed to
alert companies to the possibilities of new technology. It aims to:
inform, incite, support, fund and communicate. Launched in 1982 this
venture is increasingly successful and has produced a journal; ‘Athena’ a
meeting programme; ‘Journées Athena’ and a annual award for
innovation, the ‘Golden Owl’.
34
Co-operation is strongly directed to foreign partners, including
companies in the USA, Japan, Europe, Latin America and elsewhere.
Number of University Labs
Number of Enterprises
42
Agriculture/Sylv.
6
24
Agro-Food
8
15
Chemistry
5
113
Health Care
19
12
Environment/Energy
4
6
Equipment
2
10
Others
9
Partners in this project include, the Liposome Company, USA, and
the Institut des Radioéléments (IRE) of the Catholic University of
Louvain.
IRE-Medgenix, manufactures in vitro diagnostic agents and
involves partners, IRE and Bioassay Ltd.
In addition Wallonia is host to many Belgian and foreign multinational
companies including: Monsanto, Smith Kline Rit, Hybritech, NPI, Sanofi,
Noorden, Lederle-Cyanamid etc. The Walloon authorities have stated that per
capita investment in biotechnology is the highest in the world.
Fig. 2. Biotechnology in Wallonia
The Biotechnology Scene in Wallonia
Fifty companies and more than 250 French speaking university
laboratories are active in biotechnology. The large university contribution
emphasise that prospects for industrial/university collaboration are by no
means exhausted. More than half of the active companies were satisfied
with their university partners. Universities have gone to great lengths to
present a hospitable infrastructure by creating science parks, pilot
laboratories and R&D interfaces.
Particular regional strengths include: in vitro plant multiplication (6
companies), vaccines, therapeutics and diagnostics (9 companies),
environmental applications (6 companies) and extraction and purification of
natural products (5 companies). Notable new companies include:
Phytotec, a joint venture of Native Plant Institute, USA, and the
Belgian company, Société Européenne de Sémences, devoted to
plant development.
IRE-Celltarg, is involved in the use of monoclonal antibodies as
targeting agents for cytotoxic agents, such as radio-isotopes.
35
36
Table 1. Output of potential workers in biotechnology
1.2. DENMARK
1987
Number of
Graduates
Institution (s)
Bruno Hansen
Introduction
Biotechnology has a long tradition in Denmark. Substantial funds have
been devoted to research in both private and public sectors. Modern
biotechnology is used in many different areas of industry and in the public sector.
The following review emphasises applications of the latest
developments in biotechnology in the following sectors.
1. Manpower in molecular biology and biotechnology;
2. Public institutions including universities performing research in
molecular biology and biotechnology;
3. Biotechnological industries and their research;
4. Government funded research programmes in molecular biology and
biotechnology;
5. International collaboration;
6. Legislation concerning control of research and production.
Manpower in Molecular Biology and Biotechnology
Graduates in molecular biology are produced at the universities of
Copenhagen, Aarhus and Odense, but most workers in the field are
graduates from other institutions which have a molecular biological
component in their curriculum as summarised in the table below.
Universities of Copenhagen, Aarhus, Odense:
graduating in molecular biology, biochemistry, biology and
chemistry
graduating in medicine
Danish Technical University:
graduates in chemical engineering
Royal Danish School of Pharmacy
graduates in pharmacology
Royal Danish Veterinary and Agricultural University
graduates I veterinary science, agronomy, food technology,
horticulture, dairy science
215
560
70
70
275
1190
Total
Clearly the total is large enough to support a considerable expansion
of Denmark’s biotechnology activity. All of the above institutes also offer
advanced training and degrees, but a lack of training grants and facilities
has limited intake.
The bottlenecks have been identified as limited facilities and staff at
senior level, but the enthusiastic response of Denmark’s scientific community
to the new biotechnology indicates considerable scope for expansion.
The new biotechnology programme aims to substantially increase
research training in biotechnology. The scientific manpower available to
support the programme has a broad base of appropriate competence. The
tendency of Danish scientists to have spent time in foreign laboratories adds
further to the experience base of Danish biotechnology.
Public Institutions Including Universities Performing Research in
Molecular Biology and Biotechnology
UNIVERSITIES
As mentioned above all of the institutions shown in Table 1 carry out
research and award higher degrees. Some of the laboratories have achieved
international distinction.
37
38
Basic operating funding for university linked institutes and
laboratories comes from the university research budget, which is almost
entirely provided by the government. To supplement the government funds
there is competition for funds from agencies which include research
councils, private foundations, government research initiatives and
international initiatives such as the European Commission’s Biotechnology
Action Programme.
Almost all of the universities are involved in active collaboration,
either with other universities and institutes at home and abroad or with
industry both at home and abroad.
GOVERNMENT RESEARCH INSTITUTES ETC.
Ministry of Interior Affairs: At the Government Serum Institute, high
level research is dedicated to the production of diagnostics, sera and
vaccines. The University Hospital in Copenhagen works in close cooperation with the medical faculty at the University and with other
hospitals especially those in university cities.
Ministry of Agriculture: Gives support to several institutes active in
biotechnology, notably the Veterinary Serum Laboratory in
Copenhagen, The Institute for Veterinary Virus Research at Lindholm
and the Research Institute for Animal Husbandry at Foulum.
Ministry of Fisheries: The Institute for Fish Research at Lyngby and
Hirtshals and the Fishery and Sea Investigations at Hirtshals are both
active in aspects of aquatic biotechnology.
Ministry of Energy: At the Research Establishment in Riso plant
biotechnology and especially protoplast technology is the focus of effort.
Ministry of Environmental Affairs: Has a largely supervisory role.
Research funding is not a primary objective.
Ministry of Labour: At the National Institute of Occupational Health,
steps have been taken to initiate a programme in gene technology and
health care problems in related to modern biotechnological procedures.
industry and in some fields with the public sector. Several such
institutes are active in biotechnology, especially those sponsored by
the Academy for Technical Services, ATV. Notable are, the Gene
Technology Laboratory, Lyngby, the Danish Aquaculture Institute,
Horsholm and the Institute for Biotechnology, Kolding.
Biotechnological Industries and Their Research
Alfred Benzon A/S
A small highly specialised company operating in the molecular
biology and active peptide sector. Major R&D commitment.
Danisco A/S
Investing heavily in biotechnology, Danisco and its subsidiaries are
involved in the production of enzymes, emulsifiers food additives
and sewage treatment.
De Danske Sukkerfabrikker A/S
Active in plant genetics and membrane technology. Passage of new
rDNA regulations has prevented field trials (in Denmark) of
genetically modified sugar beet.
Chr Hansens Laboratorium A/S
Involved in production of chymosin and lactic acid bacteria cultures.
Novo Industry A/S
Novo is a major producer of insulin and industrial enzymes. With
about 4.000 employees in Denmark, Novo is by Danish standards a big
company. Almost all biotechnological activities are undertaken by
Novo, and R&D represents a very large proportion of total turnover.
Nordisk Gentofte
Is also involved in Insulin production. Other products include peptide
and protein pharmaceuticals including human growth hormone,
serum albumin and factor VIII.
Ministry of Industry: Several programmes support R&D in
biotechnology. Support is given to Technological Service Institutes,
independent, non-profit institutes working in co-operation with
United Breweries
Include the Carlsberg Research Centre and Carlbiotech. This
company has a long tradition of innovation and investment in
biotechnology. Products and interests include: enzymes, hormones,
plant molecular genetics, fermentation and protein engineering.
39
40
Other companies
Include; Aarhus Oliefabrik, Convex Biotechnology, Dansk
Sojaakagefabrik, L Dxhnfeldt, Ferrosan, Fredericia Cellulosefabrik,
Kobenhavns Pektinfabrik, Lundbeck.
Almost all Danish biotechnology companies are involved in formal or
informal relationships with universities and government research institutes.
Personal contact plays an important role in establishing these important
networks. Expensive instrumentation is often shared.
Government Funded Research Programmes in Molecular Biology and
Technology
In a well established pattern, the research councils have provided
funds for scientific research in many areas including molecular biology and
biotechnology. Applications for such funds are competitive.
The Ministry of Industry through its Agency of Technology has
supported biotechnology through a number of programmes. Two in
particular were specifically designed to support biotechnology.
T HE RESEARCH PROGRAMME FOR BIOMOLECULAR TECHNIQUE
Approved in June 1984 Parliament voted DKr33.6 million for a five
year programme of research administered by the research councils.
Table 2. The following appropriations have been made so far.
DKr 1000
1984
1985
1986
1987
Biorganic chemistry
880
741
770
870
Biostructural chemistry
400
818
850
850
Genetic stability
775
767
860
1010
Purification
150
460
690
840
Plant cells
400
511
679
680
Plant genes
0
1022
1158
1160
Reproductive biology
300
734
884
1035
Reagents and vaccines
0
460
901
1150
Total
2905
5513
6792
7595
1988
870
850
1010
840
680
1160
1035
1150
7595
RESEARCH AS A BASIS FOR TECHNOLOGICAL DEVELOPMENT
Approved by parliament in 1985, this five year programme totals
DKr300 million, with biotechnology getting DKr 60 million. The research
councils administer the funds.
T HE NEW BIOTECHNOLOGY PROGRAMME
Proposed by the government in 1986, funds were approved in
principle in 1987, but at the time of writing final programme approval has
not been given, and the following outline is necessarily provisional.
T HE DANISH P ROGRAMME FOR B IOTECHNOLOGY 1987-1990
Introduction
The recent advances in biological sciences have profound implications
for applied biology and for Danish production and export, as well as for the
environment, health care and nutrition.
Denmark must secure an independent competence in biotechnology,
characterised by an intensified national effort. The proposed national
programme has three main elements:
Biotechnology Research Centres
Education
Information and technology assessment
41
42
The programme will have a broad based steering committee with
representatives from the ministries, universities and industry.
At the time of writing more than 50 applications had been received,
covering the whole target area.
Biotechnology Research Centres will form the core of the programme.
The establishment of 6-10 centres is visualised. A centre would not be a
physical structure, but the formalised association of research groups in
institutes and industry. For a country which until recently had a clear rift
between universities and industry this is a major step. The achievement of an
intellectual critical mass is one of the objectives of such centres.
Education
Technology transfer from university to industry would be facilitated
by the centres leading to rapid commercialisation of research work.
A call for applications for grants was distributed. Applications
contain information on the qualifications of participating scientists, the
nature of the projects and proposed budgets. The biotechnology programme
is intended to supply only part of the costs, essential infrastructure being
provided by the participants. Grants would be given for the whole funding
period, and holders would have considerable flexibility to target fund
according to changing project requirements. This requires a radical change
away from closely monitored research funds.
The centres will concentrate on disciplines such as: biochemistry,
molecular genetics, immunology, growth physiology, microbiology, bioindustrial
processing technology and research must be directed to optimisation of microorganism, cell cultures and molecular biology applications.
Each centre will focus upon a large area and funding will depend
upon the quality and distribution of the applicants. It is intended that the
following areas be covered:
Molecular biology, biotechnological methods and processes
Fermentation and down stream processing
Plant production
Animal production
Marine biology, fish farming, use of aquatic resources
Food production
Environmental protection, ecology, use of waste products
Health care
43
There must be an increase in the supply of biotechnologists. Part of
the programme appropriation is aimed at increasing the output of MS level
graduates in relevant subjects.
DKr60 million has been budgeted for education in the programme to
be used in the following way:
DKr
Final year undergraduate stipends
Bottleneck courses
Curriculum development
Retraining
Instrumentation for education
Total
1987
6.0
2.0
3.5
4.5
4.0
20.0
1988
8.0
2.0
2.5
4.5
3.0
20.0
million
1989
8.0
2.0
1.0
2.0
2.0
15.0
1990
8.0
2.0
1.0
2.0
2.0
15.0
The aim of the funding described above is to increase the production of
relevant graduates to a level of 150-200 per year, increasing to 300 by 1990.
Ph.D. level research will take place in research centres, which will be
obliged to have a number of graduate students on their staffs. The centres
will also have to arrange courses, workshops etc for other scientists.
Information and Technology Assessment
There has been much concern in Denmark over the risks and ethical
concerns involved in biotechnology. Public information is a key need.
Research must also be undertaken to evaluate the implications of
biotechnology for the economy, the environment, public health and nutrition.
The information programme will focus on providing the public with
more and better material on molecular biology and biotechnology. This
should not take the form of ‘official information’. Translation of key
literature into Danish could play a part of the programme. Existing
information channels, including schools, public libraries etc. will be used
for distribution. Access to international studies on technology assessment
will be facilitated. The objective is to provide a coherent background for the
ongoing debate.
44
Overall Programme Budget
1.3. FRANCE
The following appropriation has been made for the National
Biotechnology Programme:
Research centres
Education
Information and
technology assessment
Totals
1987
50
20
1988
100
20
5
5
75
125
million
1989
130
15
Daniel Thomas
DKr
1990
130
15
Total
410
70
5
5
20
150
150
500
International Collaboration
Several Danish institutions and companies participate in the EEC
Biotechnology Action Programme 1985-1989. Denmark is also a member of
the European Molecular Biology Laboratory, EMBL, and is playing an
active role in the EUREKA programme. A Nordic collaborative programme
in biotechnology is being considered, and is seeing first fruits in agreements
on protein engineering. Co-ordination of international co-operation and
national programmes is a high priority.
Legislation Concerning the Control of Research and Production
In 1986 Denmark was the first country to enact legislation to regulate
genetic manipulation (an official English translation is available). The law
is wide reaching and precise details of interpretation will depend upon
existing regulatory procedures. The law is administered by the Ministry of
Environmental Affairs.
Introduction
France has a long and distinguished history in the domain of
biotechnology. The lasting legacy of Pasteur continues to be a world class
centre of excellence in many areas of biotechnological relevance.
While the early history of biotechnology was distinguished the recent
past has been less so. The Pasteur Institute represented the only focus of
modern biotechnology in France. Many universities and industrial
laboratories were working in relevant areas, but no overall aims or objectives
integrated the obvious potential for excellence (Institut Pasteur excepted).
Moved by the growing impact of the ‘new biotechnology’ of gene
manipulation and monoclonal antibody production, France decided to assert
its competence on the world stage. To a large extent this initiative was the
result of President Mitterand’s personal will to achieve French preeminence.
The ‘Programme Mobilisateur’
Accordingly in 1982 the ‘Programme Mobilisateur’ was launched
under the aegis of the Ministry of Technology, to cover a mobilisation in
seven strategic areas of technology, including biotechnology. The original aim
of the programme was to give France’s biotechnology industry 10% of the
world market by 1995. Spending in biotechnology by industry and government
was quadrupled from about FF250 million in 1981 to FF1 billion in 1982.
Professor Daniel Thomas of the university of Compiègne was put in
overall charge of the biotechnology programme. Provided with considerable
means, both financial and political, the programme had an immediate
rejuvenating and integrating effect on France’s biotechnology endeavour.
Special importance was given to the agriculture and agro-food sectors, vital
for long term global strategies. Of great and lasting value has been the
building of bridges between the industrial and academic research sectors.
This process is gaining momentum.
45
46
France has not failed to see the importance of international cooperation and the programme is specifically orientated to maximising the
benefits obtainable from such collaboration. No fewer than 60 countries
have sought French help in relevant areas of application and France has
much to learn from EEC partners and the USA.
P RIORITIES OF THE P ROGRAMME MOBILISATEUR
1. to assure logistical support for biotechnology
2. by consultation with the research administrations, CEA, CNRS,
INSERM and INRA, involve the scientific community in
determination of themes and priorities
3. intervene directly to initiate applied research projects that involve
industrial/academic collaboration.
4. the provision of a training programme so as to meet the needs of a
growing biotechnology industry
5. break down France’s traditional isolation by forging international
collaborations.
I. ELEMENTS OF LOGISTICAL SUPPORT
France is moving rapidly to establish the infrastructure necessary for
a dynamic national biotechnology enterprise. Aspects of the infrastructure
requirement include:
Establishment of competence in bioinformatics, to include
nucleic acid sequence data banks, crystallographic data banks,
Microbial data banks etc. There is a real need to develop a French
competence in molecular graphics. In many cases existing European
resources (EMBL for example) imply the formation of regional
nodes and will offer valuable opportunities for French participation.
II. T HEMES AND P RIORITIES
Five theme areas have been defined, including molecular biology,
microbiology, enzymology/protein structure, plants and immunology.
Gene manipulation is but a means to an end and it should be made
routinely available to all those with a requirement.
47
Microbial diversity presents a range of untapped potential.
Classification and studies in microbial physiology and genetics hold
out the prospect of valuable new products and processes. Anaerobes
in particular have been largely ignored.
Enzymes/Protein structure. With the increased capability for
tailoring genes, it is necessary to develop those tools which make
protein engineering a possibility. X-Ray diffraction, molecular
graphics, NMR determinations and the tools of molecular genetics
form an integrated package for protein design and modification.
Plant molecular biology has been recognised as a weak link in the
economic growth of biotechnology. France defined this priority area
even before the EEC. Government institutes, especially INRA (Institut
National pour la Recherche Agronomique) have international
standing. The main requirement is increased manpower.
Immunology has been the key to dramatic changes in diagnosis.
Monoclonal antibodies resulting from hybridoma technology have
created a new industry in rapid diagnosis, from pregnancy to swine
fever. French industry has moved fast to remain competitive, but
investment in basic research and training is essential.
III. INITIATION OF P ROJECTS
The first area for action is the agro-food sector and the six following
projects have been designated as being of industrial priority. Research in
these areas will have direct economic benefits to French competitiveness.
Identification and classification of micro-organisms, development
of fast diagnostic tools.
Development of competence in mixed or sequential culture
methodology in the dairy and brewing industries.
The optimisation of enzymes in media of economic importance:
complex media, heterogeneous media, non-aqueous media.
Special emphasis on R&D of milk related bacteria in all sectors of
the French food industry.
Optimisation of fermentation processes, both traditional and modern.
48
Improvements in the understanding and control of the vinification
process.
At the end of 1985 FF35 million had been set aside for these priority
areas.
The second area for action is health, where France has a number of
internationally competitive companies. Priority is to be given to the early
recognition of disease states. Biotechnology has enormous scope for
applications in preventative medicine: vaccines, diagnostics etc. for both
human and veterinary applications. The fate of proteins from expression,
through extraction and purification in commercial cultures is a priority. This
will be linked to structural studies.
IV. TRAINING
Centres of excellence, ‘Poles’ in the French nomenclature will meet
the training requirements of the scientists and engineers needed to steer
France’s biotechnology industry towards the future. Centres at Compiègne
and Toulouse are being followed by several others.
V. INTERNATIONAL COLLABORATION
The ‘Programme Mobilisateur’ is committed to close collaboration
with European initiatives such as the BAP and BRIDGE programmes of the
EEC and the EUREKA programme. The contribution of industry to these
collaborative ventures will be critical. The Versailles Summit in 1986
defined the need for an international biotechnology network. France already
contributes to model structures such as EMBL (France contributes 22% of
operating funds).
France has recognised the potential of collaboration with Latin
America. A French delegation visited Argentina in 1986 and Brazil in 1987.
Mexico has an established collaboration with France in the field of
fermentation in the solid phase. ORSTOM, concerned with French overseas
relations with the 3rd world is concerned with the potential of
biotechnology to add value to marginal agriculture.
49
Public Institutions in Biotechnology
France has an established tradition of excellence in many fields of
fundamental and applied research. The ‘Programme Mobilisateur’ referred
to above rectifies an omission in the case of biotechnology. The research
organisations active in biotechnology include the following: Centre des
Etudes Nucleaire, CEA; Centre National de la Recherche Scientifique, CNRS;
Institute National de la Recherche Agronomique, INRA; Institut National de
la Santé et de la Recherche Medicale, INSERM; Institut Pasteur and the
universities.
All of these organisations now have a structure which permits
academic-industrial technology transfer. The Pasteur Institute is now a
hybrid organisation with commercial and basic research activities.
The CEA, rather like equivalent institutions in W Germany and the
United Kingdom has peripheral, but significant interests in
biotechnology. These range from the obvious association of radiolabelling and diagnostics, through to the development of an
independent competence in much of the relevant molecular biology
and immunology.
The CNRS is France’s leading agency for the funding of
fundamental research. It has many institutes and employs a large
number of France’s fundamental research workers. Increasingly the
CNRS is responding to the call for more applied research trends. The
CNRS has played a major role in developing molecular biology and
immunology in France.
INRA has always had a strong commitment to applied agricultural
research. In recent years it has made determined moves to be at the
forefront of biotechnology. Research on animal vaccines and
immunogenicity is world class. INRA has several exclusive licencing
deals with French companies, particularly in the area of diagnostics
development.
INSERM, with its responsibility for medical research has always
had applied research as a major part of its portfolio of work.
Immunology research is one of INSERM’s foci of excellence. INSERM
is moving towards a clearer interpretation of its role in a scientific
climate that increasingly heeds the call of economic necessity.
50
has close relations with the newly founded company
Immunotech, which commercialises the results of research. This
involves a far greater degree of communication with other
institutions and industry. Other areas of activity include the
development of new bioactive agents, lymphokines and artificial
vaccines.
INSERM
A fourth category of biotechnology companies would be the large
agro-food companies with a small activity in the field. Such companies are
typified by Fromageries Bel, Moet Hennessey, Gervais-Danone.
The interest level and commitment to biotechnology varies from
Sanofi’s state of the art competence in rDNA and expression systems, to a
straightforward requirement for better process control in the cheese industry.
The Institut Pasteur has a purely commercial division, Pasteur
Production, a classic example of government privatisation. It is
responsible for vaccine production and therapeutics. Its cell culture
facilities are outstanding as are the basic biology support services.
Research in the government sponsored Institute proper is supported by a
number of funding agencies and covers areas as diverse as chromosome
structure, microbial physiology and AIDS. Government funds of FF100
million are targeted at the disease, much of the spending is on the
Pasteur facilities, which have developed sensitive tests.
The universities also make a contribution to biotechnological
research. The university of Compiègne and certain other facilities are
developing strong industrial and institutional links.
The Biotechnology Industry
The French biotechnology industry is dominated by three large
pharmaceutical companies, Rhône-Poulenc, Roussel-Uclaf and Sanofi with
in addition a much less significant ‘second division’ including both agrofood and pharmaceutical companies such as Bertin, Mérieux, LafargeCoppée, Limagrain, Moet-Hennessey, Serono.
Unlike the USA France has not seen a wave of opportunistic start ups
in biotechnology. There have however been a number of company launches
from the public sector and from big industry. Companies such as
Immunotech, Transia and Transgène would fall into this category.
Transgéne is a start up funded by predominantly government originated
funds. An increasing proportion of the ownership has been acquired by
private investors. Transia is a genetic engineering company set up by a
consortium of agro-food industry. Biosys is a university of Compiègne spin
off in the immunoogicals area. Venture capital funded launches are few and
include Clonatec.
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52
1.4. THE FEDERAL REPUBLIC OF GERMANY
Helmut Zeittrager
Introduction
Our society needs technical progress. Globally, developments are
taking place at a furious pace, in the information and communications
technologies, in new production techniques, in biotechnology and in
the development of new materials. These offer opportunities, but also
carry with them dangers. We know that not everything that is humanly
possible is suitable for mankind. This is the challenge which we have
to face. We must seek to remain master of the technology.
The government of the FRG was one of the first to recognise the
strategic significance of biotechnology. By 1974 the BMFT
(Bundesministerium für Forschung und Technologie) had already begun the
promotion of biotechnology. Dechema (Deutsche Gesellschaft für Chemisches
Apparatwesen), an industrial representative body for the chemical industry
played a role in dissemination of information and in 1978 was instrumental
in founding EFB, European Federation of Biotechnology.
The Federal government subsequently drew up a programme for
applied biological and biotechnological research for the period 1985-88.
Biotechnology was given a central innovative role among the applied
sciences. The following research objectives were defined:
The
German
Biotechnology
Co-ordinating
Committee,
Arbeitsgemeinschaft Biotechnologie, was founded in 1978 and acts to
integrate biotechnology activities in both industry and academie sectors.
The first German biotechnology programme, the ‘Leistungsplan’
(Performance Plan) was launched in 1979. It incorporated many of the key
proposals made by Dechema in collaboration with the BMFT. In the period
1979-84 a total of US$350 million was allocated to biotechnology.
to evaluate opportunities and hazards, introducing appropriate
safety regulations and debating ethical considerations at an early
stage of progress.
Other government departments supporting research in biotechnology
include:
Deutsche Forschungsgemeinschaft, DFG, who focus on basic
research. In 1984 bioscience funding accounted for US$107 million,
one third of the total funding. DFG is an association of universities
funded by local and federal government.
BMWi, Federal Ministry for the Economy.
BML, Federal Ministry for Agriculture.
The BMFT is keenly aware of both the opportunities and risks
presented by biotechnology. Their position is summarised in a booklet
obtainable from the BMFT in Bonn, FRG.
to promote top quality science in areas relevant to the future
competitiveness of the state.
to promote the training of a new generation of biotechnologists.
FEDERAL FUNDING
At the beginning of 1986 it was announced that the total Federal
funding for the period 1984 to 1989 would be increased to DM 1.14 billion.
Roughly 1/3 was targeted to institutions and another 1/3 to four new gene
centres, other centres of excellence and infrastructure, including support for
new biotech ventures. The bulk of the remaining money is designated for
development of facilities in ‘bottleneck’ areas such as cell culture
technology, fermentation, enzymology, plant biotechnology etc.
One of the essential components of the present funding is a generous
investment in the essential enabling science for biotechnology. The federal
government has accepted that this is essential if the commercial focus of
biotechnology is to be mastered.
In a major policy speech in May 1983, the Chancellor defined the
government position with regard to biotechnology:
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54
Table 1. Federal Spending on Biotechnology, in millions of DM.
1984 1985 1986 1987 1988
Institutional funding
EMBL, EMBC, GBF etc.
37,4
45,2
59,2
69,2
67,1
Gene centres and
14,3
19,0
24,0
26,0
32,0
strategic projects
Indirect support of
2,0
2,0
15,0
27,0
35,0
industry, databanks etc.
Support for essential
0,7
2,0
3,2
3,8
3,8
technology
Technology Theme
11,3
13,0
14,0
16,8
20,4
Support
Microbial technology/
13,9
19,3
16,0
16,2
16,5
gene technology
Cell culture
10,6
14,0
18,3
21,8
33,5
Bioprocessing/
enzymology
New technology/ inter12,4
2,3
2,0
6,5
9,2
disciplinary activity
Plant and Animal
Research
Plant culture and raw
3,2
5,5
5,0
6,0
7,0
materials
Alternatives to animal
research/ biological
5,6
10,0
18,6
19,9
20,4
safety
Totals
111,4 132,3 175,3 213,2 244,9
1989
Total
58,1
336,2
37,0
152,3
40,0
121,0
2,5
16,0
24,6
100,1
16,6
98,5
42,2
140,4
13,0
45,4
8,0
34,7
22,6
97,1
264,6
1141,7
In addition to the broad themes outlined earlier, the BMFT has
identified several specific objectives, some of which are detailed in Table 1,
above. Many of these ‘bottlenecks’ require commitment of new manpower
resources, available only education at high school and university level is
appropriately orientated.
55
Genetic manipulation
Bioprocessing
Enzymology
Interdisciplinary measures
At the forefront of much of this work will be the university sector
and government research centres, most notably, GBF, Gesselschaft für
Biotechnologische Forschung, in Braunschweig and the Kernforschungsanlage,
KFA, Julich. These two centres backed by both federal and regional funds
have become showpiece institutes. The GBF went through a difficult period
in the early 1980s and there was even question of closure. Appointment of
the Present Director, Professor Joachim Klein preceded a dramatic turn
around in the fortunes of GBF. Strong backing from the regional government
of Lower Saxony has been a major spur to success. Like GBF, KFA is
strongly backed by local government, North Rhine Westphalia. Dialogue
with industry will be an essential component of long terra project planning
for both Centres. Most untypically, the BMFT is prepared to consider the
funding of projects over a period of up to 15 years.
T HE B IOTECHNOLOGY INDUSTRY IN GERMANY
To achieve these ends the BMFT has instituted a process of consultation
with Deutschen Forschungsgemeinschaft, DFG, the federal science research
funding body; Max-Planck-Gesellschaft, the very wealthy research foundation
with institutes both in Germany and abroad; and the Verband der Chemischen
Industrie, VCI, the German Chemical Industries Association.
Already mentioned are:
Approximately 100 companies in Germany have a significant
involvement in modern biotechnology. Many other companies, notably in
the food and beverages sector, have a peripheral involvement. The scope of
involvement is very large. Giant firms such as Hoechst are interested in
biotechnology in a number of areas from insulin production to insecticide
resistance. Small companies such as Biosyntech can offer services such as
custom nucleotide or peptide synthesis. On the technical side engineering
based companies can supply fermentor and bioprocess technology.
Total industrial biotechnology R&D expenditure in FRG for 1985 (last
year for which results are available) amounts to about DM 700 million,
based on biotechnology related sales of DM 20 billion.
To date it is true that the bulk of investment and production has been in
the pharmaceuticals and diagnostics sectors. In the long term there will be a
gradual increase in the emphasis of agricultural applications and plant genetic
engineering. The strong Green movement is a force to be reckoned with, even
by the strongest companies. One embarrassing incident involving the
Heidelberg based firm Gen-Bio-Tec occurred when they failed to notify the
56
Safety Commission of their work on expression of anti-clotting agents in
bacteria. Gen-Bio-Tec was at the time in receipt of major Federal and
regional support. For weeks the future of that support was placed in doubt.
Facilities to enable new biotechnology start-ups are becoming more
available. Venture Capital, in particular, is becoming readily available to
firms with a sound technology. Unlike the USA, genuinely high risk
investment is unavailable. In the past five years almost thirty significant
new start-ups have been established in FRG.
Dechema plays a central role in representing the interests of German
biotechnology companies and provides a forum for discussion and debate in
the famous Achema congress series. Held every three years Achema is one
of Europe’s most important shop windows on chemical engineering and
biotechnology. Themes treated include sociological issues arising from
public concern at issues such as genetic engineering.
The Hannover Biotechnica series of fairs, held annually was
launched in 1985 and is already rivalling Achema for prestige in the field of
biotechnology. Although backed by Lower Saxony, the Hannover fair has
no direct relation with the GBF, although GBF and other local enterprises are
given very prominent pavillions.
SECTORIAL CONTRIBUTION OF B IOTECHNOLOGY
Pharmaceuticals is a major business area in FRG, with companies
such as Hoechst, Bayer and BASF as giants in the first rank. Medium sized
companies include Boehringer-Mannheim, Boehringer-Ingelheim and its
pharmaceutical subsidiary Thomae. Henkel, Merck and Schering. All of
these have involvements beyond pharmaceuticals. Specialist pharmaceutical
companies of medium size would include Behring, Biotest and Knoll. Many
of the new start-ups are active in pharmaceuticals and have staffing levels
of 5 to 100. Examples of these include Bioferon and the Bissendorf Bio
technology Group.
There is a strong emphasis on the latest developments in biotechnology.
Pharmaceuticals in trials and production include, insulins, coagulation factors,
monoclonal antibodies, urokinase, antiviral agents, interferons, lymphokines,
interleukines, TPA, TNF, recombinant vaccines. Market projections for 1995
show a domination by products based on the new technology.
57
Agriculture is receiving more attention now. Both the Federal and
regional governments are defining this as a priority area. Action by the
European Commission is helping to focus attention on the prospects for a
post subsidy agriculture. The creation of genetically engineered plants is a
delicate issue in the FRG. Field release of such plants is subject to fiercely
critical scrutiny by both ecologist groups and the governments. The incentive
for carrying out such work in Germany is accordingly very small. In
university departments, such as Hannover and Bielefeld and at the MaxPlanck Institute for Plant Breeding in Min, work nonetheless continues into
such vital goals as increased nitrogen uptake by cereals and other crop plants.
Unless there is a campaign to stimulate awareness of the value of
biotechnology for agriculture, it is likely that the industrial contribution to
research in Germany will be limited.
Chemical Industry. The application of enzymes to the cost effective
production of both raw materials and speciality chemicals in stable
bioreactors is receiving dose attention. Centres such as GBF are
collaborating with industrial laboratories so as to engineer temperature
stable enzymes, capable of working effectively in both aqueous and nonaqueous solvent systems. Microbial leaching and concentration of high
value elements and compounds is receiving attention from the metal
extraction industry. Many of the large chemical companies are moving into
more biological applications areas as the potential of biotechnology
becomes apparent. Such activities would include applications of microbial
polysaccharides and crude oil recovery.
ENVIRONMENTAL P ROTECTION
The microbial breakdown of waste figures largely in a number of
sewage specialist companies. The strong ecological groups in the FRG make
it politically expedient for the government of the day to make considerable
moves to meet their demands. Biological treatment of effluents with
engineered microbes remains unlikely in the present anti-release climate.
University joint ventures are in favour with the government and there
is considerable pressure on industry to participate. The new Gene Centres
have been founded partly with industrial support.
The University Sector, including the Max-Planck Institutes and state
funded institutes still carries out the bulk of research in biotechnology,
58
particularly at the precompetitive level. As intimated earlier strategic
collaborations with industry are increasing in number and quality, although
fears about industrial confidentiality may cause some concern. With
government support, general excellence in over 300 departments of
biological sciences has crystallised into the formation of four Gene Centres
located at Min, München, Heidelberg and Berlin. These centres were
established around existing centres of excellence, but the inflow of central
funds has allowed the elaboration of new building and equipment.
One of the central weaknesses in the FRG’s biotechnology has been the
traditional University/Industry divide. The FRG has jealously dung onto the
demarcation, well after its abandonment by many other European states.
Among academics pure research still has enormous ‘cache’ compared with
applied industrial research. Salary differentials, while significant, do not
mean the difference between a bearable and good standard of living. In the
FRG academics earn a comfortable living. Biotechnology itself is one of the
forces bringing about a reappraisal of the situation as fundamental rapidly
becomes applicable. Unfortunately industrial support of ‘academic research is
concentrated on institutes such as GBF, Braunschweig or KFA Julich, rather
than universities ‘per se’. Institutes such as the German Cancer Research
Centre in Heidelberg have played a useful role in creating a respectable
image for applied research. EMBL, the prestigious international laboratory,
also in Heidelberg, is also strengthening this consensus by establishing more
links with industrial ventures, including the licensing of know-how.
The road to a doctoral level qualification is very long. A diplom
awarded at age 25 or 26 must be followed by up to five years research
before the award of a doctorate. There is much opposition to changing the
system, although many percieve it to be overdue.
CONSEQUENCES OF THE BMFT B IOTECHNOLOGY INITIATIVE
In the context of enabling technology for biotechnology, the BMFT
initiative has provided substantial funds for universities to do work in
bottleneck areas such as: bacterial physiology, plant physiology and
biochemistry and bioprocessing technology (see Table 1).
The Gene Centres are designed to radically upgrade German
competence in the field by giving substantial funds and prestige to already
recognised centres of excellence. The research aims of these groups are:
59
elucidation of genetic structures;
action and interactions of genes;
control of gene expression.
The Köln Centre based on the Max-Planck Institute for plant culture
research and the University Genetics Institute is concerned with plant
genetics and the use of plants for the expression of foreign genes, plant cell
culture and micropropagation, the genetic basis for nitrogen fixation. Other
work focuses on viral genetics and general aspects of cell biology and
biochemistry.
The Heidelberg Centre, located at the university with input from the
Cancer Research Centre focuses on microbial genetics, virology and
Immunology. Work is targeted at medical problems: diagnosis, therapy,
neurobiology etc.
The Munich Centre links the University and the Max-Planck Institute
for Biochemistry. Work focuses on the development of sequencing
technology and chemical synthesis of genes. Ancillary work in immunology
and cell biology builds upon this competence. Plant cell biology focuses on
gene transfer.
The Berlin Centre continues the thrust of excellence in gene
technology and draws upon the skills of the Max-Planck Institute for
Molecular Genetics, which is world renowned. Analogous to the Gene
Centres are two BMFT designated Centres of Excellence in bioprocessing
technology. These centres are designed to provide a skill and knowledge
base for the fundamental skills which underpin commercial processing
technology. The first centre has been established in Lower Saxony and
receives input from the universities of Braunschweig, Göttingen and
Hannover, and the GBF, Braunschweig. GBF is the leading German centre
for process and fermentation technology. Its diversification into other areas
of biotechnology has secured a status unparalleled.
The Lower Saxony Centre will have its centre of gravity in
Braunschweig and will concentrate on the enzymatic and microbial
processing of carbohydrates. Antibiotic production processes, animal cell
processes, culture development, cell reactions and measuring methodology.
Computer and information systems research will support control system
60
development and data treatment. Bioreactor development will be an almost
automatic consequence of the skill base in Lower Saxony.
The second centre, associated with the University of Stuttgart started
work in 1987 and 1988 and consists of five institutes focusing on Bioprocess
Engineering, Biochemical Engineering, Applied Microbiology, Applied
Genetics and Mammalian Cell Culture.
OTHER S TRATEGIC P ROJECTS
The development of biotechnology worldwide demands a flexibility
of response from the German research base so as to maintain competitivity.
Interdisciplinary fertilisation (electronics/enzyme technology) is seen as
critical. New centres could and will be designated as appropriate. Topics
under consideration include biocatalysis, chemical synthesis of peptides and
genes, protein engineering, etc. New centres will include both institutional
and industrial representation to a greater extent than is presently the case for
the Gene Centres. GBF has broken this ground by establishing a healthy
portfolio of industrially funded projects.
INDIRECT MEASURES
Might include the financing of studies on aspects of regulation, or the
provision of training funds for specific problem areas. The provision of
funds in this category is deliberately flexible.
ENCOURAGEMENT OF ENTERPRISE
The BMFT is keen not to lose the innovative potential of academic staff
and especially staff in small and medium scale enterprises in the
pharmaceutical and chemical industries, in the food industry. Such
innovations could have applications in sectors such as plant biology,
industrial scale production, commercial microbiology etc. Bioreactor
technology could be encouraged by stimulating joint venture activity between
equipment, engineering and research activities. To meet such need funds shall
be available to encourage product orientated innovation in biotechnology.
ENCOURAGEMENT OF THE B IOTECHNOLOGY INDUSTRY
Industrial potential in the biotechnology industry is to be reinforced by
targeted BMFT support. The basis of support is the provision of training and
support for acquisition of the latest in biotechnological methodology. Such
support should cushion the risk undertaken by industry active in these areas.
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AREAS TO BE T ARGETED FOR SUPPORT
Cell culture
Gene manipulation
Process technology using plant animal and human cells and
manipulated micro-organisms.
Enzyme technology for medical and food applications
Apparatus and equipment development
Bioreactor development, measurement and control systems
All independent enterprises with an interest in the above areas should
be eligible for support up to the level of 40% of costs to a maximum of
DM600 thousand per enterprise. Other funds for personnel, equipment etc
are available. Total budget for this programme was fixed at DM100 million
over four years from January 1986.
T RAINING FUNDS
To provide the manpower necessary to sustain growth, the Federal
government has designated training as being a major priority and
accordingly has provide substantial funds. Training funds are targeted at
three areas:
International scientific collaboration
Biological chemistry
Biotechnology further training
Generally speaking the training is orientated towards the areas
previously defined as important.
ENCOURAGEMENT OF ACADEMIC/INDUSTRIAL COLLABORATION
Particularly in the area of precompetitive research it is seen that a
dose relationship between factory and university could be beneficial for the
Federal Republic. Areas of particular interest in this context would be
environmental projects and risk assessment projects that could take place
without any threat to industrial security. The work in this area could be
chosen on the basis of national and international importance. Flexibility in
approach and execution of such projects is seen as essential. To this end the
normally detailed and frequent review procedures will give way to a less
tightly controlled assessment procedure. The basic project areas could lie in
the same theme regions as previously outlined:
62
Microbiology and microbial genetic techniques;
Cell culture and cell fusion technology;
Enzyme technology;
Biological processing (including food technology);
Plant and animal research;
Safety research.
Other areas may be defined with the growth of knowledge and
experience. The dialogue between science and industry will in itself achieve
further definitions. Many areas of development essential to long term industrial
competitivity could be developed. In some cases collaborations similar in
concept to the British and French club themes would be used to provide
enabling technology to a number of client companies and universities.
To identify just a few project areas noted by the BMFT.
Microbial Technology
Gene transfer technology to improve microbial cell culture yields etc.
Genetic stability, ecology and toxicology of mixed microbial cultures.
Possible applications of mixed culture techniques.
Safety and Technology Monitoring
Development of safer fermentation and bioprocessing technologies for
genetically manipulated organisms and their products. Socio-economic
aspects of biotechnological developments
New Areas of Applied Biology
Fusion of biomolecular and microelectronic technologies Enzyme
design and protein engineering, gene synthesis
Other areas of significance include: microbial screening, effluent
microbiology, microbial collections, gene technology projects, human and
animal cell potential, plant cell evaluation, biocatalysis, enzyme production,
biocatalyst based production, new bioreactor systems, upstream processing,
control technology, plant breeding and raw materials, natural product
screening, alternatives to animal research, ecological impact of genetically
modified organisms, safety and genetically modified organisms.
INTERNATIONAL COLLABORATION
Development, control, standardisation of bioindustrially interesting cell
lines
Development of cell storage techniques
The BMFT places great importance on collaboration with other EEC
member states, especially within the framework of EEC mediated
collaborative programmes such as BEP (Biomolecular Engineering
Programme), BAP (Biotechnology Action Programme) and projects such as
ECLAIR which seek to study alternative, bioindustrial, applications for
Europe’s agricultural potential.
Enzymology
Biocatalysis, stability and characterisation of immobilised and carrier
associated enzymes, enzyme complexes and cells.
The OECD initiative in determining regulating principals for
molecular genetics is welcomed by the FRG. Collaboration with the OECD is
a valuable aspect of international collaboration in biotechnology.
Cell Culture
Bioprocessing
Bioreactor mechanics, construction and applications
Evolution of biosensors for process monitoring
Plant and Animal Biology
Development of plants for food, raw material and environmental
applications
Diagnosis, prophylaxis and treatment of animal disease.
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Collaboration with industrial nations is largely focused on Europe
and to a lesser extent the United States. Realisation of the Japanese
Human Frontiers Programme may well involve German groups.
Collaboration with developing nations is a theme of several recent
initiatives. Notably, the GBF Braunschweig has initiated a programme
of training specifically targeted at the requirements of developing
nations.
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The Role of the GBF, Braunschweig
The GBF was Europe’s first dedicated centre for research and
development in biotechnology. After a period of uncertainty, the
appointment of the present director, Dr Klein has given GBF a powerful and
widely appreciated authority in many areas of biotechnology.
Originally founded by the Volkswagen foundation, the GBF has since
1976 been cofunded by the Federal government (90%) and the regional
government of Lower Saxony (10%).
The main research areas of the GBF are:
Microbial products of synthesis and biotransformation;
Molecular and cell biology of biologically active proteins;
Industrial enzymes and protein design;
Development of bioprocessing.
In addition the GBF has played host to the German Collection of Microorganisms, DSM, since 1979. A separate legal entity, DSM is poised for
commercial exploitation as one of the world’s foci of microbial strain
deposition.
In addition to precompetitive applied research, the GBF has a number
of confidential collaborative projects in hand. While GBF can not be as
secure as an industrial laboratory, the industrial partners in such contract
research have been well satisfied with the GBF’s role in such collaborations.
Protein Design was launched as an interest in 1985. In the past year
development of hardware and software components of the system has
matured and this area looks set to become one of GBF’s principal activities.
Potential for partnerships with industry and commercial exploitation of this
growing know-how is large. The pharmaceutical industry is particularly
interested in the prospect of exploiting protein engineering for the
production of new or modified biologically active peptides.
The fermentation and bioprocessing facilities of GBF are first rate and
already act as a focus for industrial development and pilot studies. The
‘Biotechnikum’ is equipped with fermenters up to 5.000 liters capacity.
Down stream processing facilities can be used to model processes up to
semi-industrial scale – a valuable national resource. The ‘Biotechnikum
Service Unit’ gives back-up to process engineering when no commercially
65
obtainable support is available. Such back-up might include the production
and isolation of materials not available on the market.
Sophisticated computing and spectrographic facilities back up all
aspects of development work, and contribute to a growing excellence in the
understanding and implementation of novel process control systems.
Licensing of GBF technology is possible, although offered preferentially to
German firms.
Almost all of the FRG’s major chemical and bioscience companies
have entered into collaboration with the GBF in at least one project over the
past ten years. Roughly 1/3 of GBF’s industrial partners are foreign, the
majority from Europe. The opening up of new industrial contacts and
ventures is facilitated by an outward looking attitude characterised by
seminars and invitations in both industrial and institutional laboratories.
The German Chemical Industries Association has created a GBF support
group to strengthen industrial appreciation of the resource.
GBF has about 425 staff of whom 160 are scientists. The 1987 budget
amounted to almost 70 million DM, including a large 61 element of new
building support, which should do much to alleviate the recent
overcrowding problems.
GBF has noted the potential of developing countries to benefit from
several biotechnological advances. Without adequate training and local
expertise such advances cannot be applied. The provision of trained
scientists is a choke point which GBF aims to remedy by an in-house
training programme. Already three course have sent 60 third world
scientists back to their home countries with an appreciation of the modern
technologies and their applicability in a third world environment.
Of 250 applicants for the first course the 20 selected included five
from Latin America. All costs, including air fare, were born by the GBF.
Lower Saxony has made clear its intention to become the foremost
region for German biotechnology. Recently it became committed to
supporting three biocentres collaborating with the GBF, Braunschweig
Technical University, the University of Hannover and the University of
Göttingen. This structure will give the area a solid mass of excellence. The
only problem foreseen is that of staff recruitment.
66
Growth in biotechnology is characterised by the rapid expansion of the
Bissendorf Biotechnology group. Next to GBF they have launched a major
peptide and protein production centre, Braunschweiger Biotechnologie.
1.5. GREECE
Presentations by Drs Tzotzos and Dourtouglou
Presentation by George Tzotzos
INTRODUCTION
Greece’s economy has several similarities with that of Latin
America. Emphasis is placed on services and traditional agri-industries,
while Greece’s chemical industry was heavy commodity and obsolescent;
unable to incorporate biotechnological advances.
In Greece as a whole the worldwide trend, of movement away from
manufacturing to service industries, is being observed. The Greek scientific
community has two components, a small domestic element and a large and
conspicuously successful international element.
To encourage the development of an infrastructure capable of
supporting a Greek biotechnology industry the government launched
incentives for the repatriation of Greek scientists. These took the form of
two international centres of excellence
The Institute of Molecular Biology and Biotechnology, IMBB, at
Heraklion, Crete and:
The Hellenic Institute Pasteur launched a hybridoma and
monoclonal antibody facility.
Participation of Greek scientists and laboratories in European and
ventures such as EMBL/EMBO and the BEP and BAP programmes has
increased the flow of knowledge and awareness in biotechnology.
EEC
With the support of the government the first Greek biotechnology
company, Biohellas, has recently been launched.
These measures have provided a solid basis for encouraging the
repatriation of Greek scientists working overseas.
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68
W HAT EXPERIENCE HAS B EEN GAINED IN THE P AST F OUR YEARS?
1. Finance, management and marketing are integral parts of the
biotechnology process. Small economies cannot meet demand for
these skills at an adequate level.
2. R&D scale-up is investment intensive, making redundant the
notion that biotechnology is cheap.
3. Expertise in microbial physiology and fermentation is embryonic
in Greece and probably elsewhere too. Training in biochemical
sciences is no panacea.
In the light of the above it appears unlikely that transfer of
technology and strengthening of the biotechnology industry can be achieved
without a coherent policy focusing on target definition, commitment of
resources and openness to the scientific and entrepreneurial communities
beyond national borders. The latter is of paramount importance particularly
in cases where national economies are unable to sustain technological
growth at the required pace. Greece’s efforts to overcome the problems,
briefly outlined above, is presented in Dr Dourtouglou’s paper.
ROLE OF THE S TATE
A number of ministries have interests in biotechnology and the
following all have a budgetary allocation for biotechnology.
Ministry of Energy, Industry and Technology, General Secretariat
for Research and Technology;
Agricultural Ministry;
Health and Social Security Ministry;
Ministry of Environment and Urban Planning;
Ministry of the National Economy.
As yet there is no formal interministerial co-ordination, but the
Research and Technology Secretariat has drawn up a plan which considers
other ministries and research interests in biotechnology.
The Research and Technology Secretariat may gain the authority to
steer national biotechnology policy with the approval of all ministries.
Three laboratories in Greece can be considered to have significant
resources in biotechnology. These are:
Presentation by Dr V. Dourtouglou
Greece has come to appreciate the potential of modern
biotechnological innovations. Interest in government circles was first
stimulated at the beginning of the 1980s, when a national support policy for
both private and public sector involvement in biotechnology was outlined.
Of primordial importance in assisting Greek biotechnological
development is the provision of training. In the medium term such training
should be geared to industrially relevant aspects of biotechnology such as:
positive cash-flow situation. The role of state intervention is therefore critical
to the development of a domestic biotechnology enterprise.
enzyme engineering;
bioreactor use and development;
diagnostic kit development;
agricultural biotechnology, micropropagation etc.
With no advanced industrial base available to assist the development of
biotechnology and no suitable funding structures in Greek financial markets,
it must be assumed that only by 1994 will Greek biotechnology enter a
69
IMBB Heraklion
Centre for Biological Research of the National Research Foundation
Hellenic Institute Pasteur, Athens
Since 1979, university research work has received government
backing, but as explained elsewhere, Greek universities are viewed
primarily as training, not research, establishments.
Despite the identification of biotechnology as a national priority, the
production capacity of existing related industry has limited both project
development and proposals.
With the support of the government, two investment banks a the
Pharmaceutical Producers Association of Greece launched the first Greek
biotechnology company, Biohellas, in 1984. Today two companies in Greece
have a significant biotechnology commitment, the second being Vioryl.
70
Having manifest the industrial application of biotechnology as a
priority, the government passed legislation to aid investment in advanced
technology. Guidance was given to universities and secondary education so
as to achieve an output of graduates able to support commitment to high
technology. The universities have responded by organising training
programmes in rDNA and other aspects of biotechnology.
With 20% of the national workforce in agriculture, it was logical to
place emphasis on agro-biotechnology, including the support of small
companies active in micropropagation and biomass. Other areas include
waste treatment and diagnostics of agricultural relevance.
A number of small firms are commercialising agricultural aspects of
biotechnology, in vitro technology and micropropagation. The Ministry of
agriculture should be approached for information on these firms.
EEC support is helping both industrial and academic laboratories to
build fruitful relationships with other biotechnology laboratories operating in
the EEC. These ventures will make a large contribution to the Greek
knowledge base in precompetitive research relevant to biotechnology industry.
There is, in conclusion, much in the Greek experience of
biotechnology that could be of direct relevance to developing countries
interested in the possible benefits of biotechnology based industrial ventures.
To obtain a redeployment of skills, retraining and reorientation
towards high technology is perceived to be of importance.
F INANCING B IOTECHNOLOGY
A rapidly growing slice of the total R&D budget of 15.56 billion
drachma is being spent on biotechnology.
Year
1984
1985
1986
Dr Millions
160
358
638
A relatively large percentage of biotechnology spending is being
devoted to agricultural applications, centred on a number of sites and institutes.
Healthcare biotechnology is an important area and relevant research
is focused on the IMBB and the Hellenic Institute Pasteur. It is still too early
to see the consequences of spending in health care and agriculture. In
industry the first concrete manifestation of progress is Biohellas, but here
too many projects are in development rather than commercial exploitation.
Biohellas has a privileged relationship with IMBB, with a licence to
commercialise IMBB developed innovations.
Vioryl is more independent of government support and has
successfully commercialised pheromone technology. It is now trying to
master monoclonal antibody production. Other interests include biocatalysis.
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72
Prepared by the biotechnology group, National Board for Science and
Technology (now replaced by BioResearch Ireland), presented by Brendan
Finucane
There is also activity in other sectors, eg Biocon Ltd manufactures
enzymes and other speciality chemicals for the food industry. Interbio
Laboratories also manufacture microbial cultures for water and waste
treatment and other purposes. A number of chemical and food firms are also
using biotechnological processes in their manufacturing. These include
Pfizer Chemical Corporation (Citric acid manufacture), Wheat Industries
Ltd (Glucose/Dextrose Plant) and Carberry Milk Products (Alcohol
production from by-product whey).
Introduction
Biotechnology Research Centres
An Irish National Biotechnology Programme was initiated in 1983 by
the National Board for Science and Technology, and the Industrial
Development Authority. The programme’s objective is to promote and
assist the application of biotechnology in Irish industry, agriculture and
other areas of social and economic development.
As in many countries, much of Ireland’s expertise in biotechnology is
located in universities and other higher level colleges.
1.6. THE REPUBLIC OF IRELAND
Brendan Finucane and Staff of BioResearch Ireland, Dublin
The major areas of application in Ireland are in agriculture/food, and in
the healthcare and pharmaceutical industries. Agriculture occupies 15% of the
Irish workforce directly, and the food and drink industry employs 26% of the
industrial workforce. Exports in 1986 of food and drink were worth over
US$3.2 billion or 23% of total exports. It is thus a very important sector and
one in which biotechnology can play an important role.
The healthcare and pharmaceutical sector is also important for
Ireland and has undergone considerable growth in recent years. The
Industrial Development Authority, IDA, has been very successful in its
efforts to attract pharmaceutical and healthcare companies to Ireland. Over
100 overseas companies in this sector now have Ireland based production
plants, including 10 of the world’s top 15 pharmaceutical companies.
Exports totalled IR£ 1.5 billion in 1985 and are growing at 40% per annum.
There has been a particularly encouraging growth in the Medical
Diagnostics area of the healthcare industry. Among indigenous companies,
Biocon, Bioprep and Noctech Ltd are manufacturing a range of products
based on enzyme immunoassays, while Beckman, Technicon, Organon and
Flemming GmbH are examples of transnational companies which produce
diagnostic products in Ireland. The industrial strength of this sector and the
fact that biotechnology has great immediate application made it an obvious
area for national development.
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Because almost half of the Irish population is under 25, Ireland has
invested heavily in scientific and technical education. In line with our policy
to develop Ireland as a centre for high technology industry, new colleges and
new laboratories have been built to cater for technical education. Science,
engineering and other technical graduates are an increasing proportion of the
output of these colleges. They represent 41% of the primary degrees and 45%
of higher degrees awarded by Irish colleges in 1985. The research facilities in
biotechnology have also been improved and individual colleges have agreed
on specific priority areas for biotechnology research.
Other centres of expertise include the following government funded
agencies:
Institute for Industrial Research and Standards, which performs
research on fermentation process scale up, enzyme technology and
monoclonal antibodies.
The Agricultural Institute, which has a staff of 1300 in 7 major
research centres throughout the country, is also involved in research
and application of biotechnology in food and agriculture.
Areas of Biotechnology Expertise
The major areas of expertise in Ireland are:
Genetic Engineering
Diagnostic Technology
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Specialty Chemicals and Pharmaceuticals
Biopharmacology
Mammalian Reproductive Technology
Plant Biotechnology
GENETIC ENGINEERING
Research is conducted in 6 of our 7 colleges; but particularly in
Trinity College, Dublin and the University Colleges of Cork and Galway.
Microbial Genetics is the main area of interest at the Dept. of Genetics,
Trinity College Dublin, where the research team of Prof. David McConnell
have performed work for many companies, including Arthur Guinness and
Co., Biocon Ltd., and ICI. This Group have recently signed a research
agreement with the Agricultural University of Beijing to jointly done the gene
for Porcine Growth Hormone. The research for Arthur Guinness was to done
the gene for glucanase into brewing yeast strains. Guinness have recently
located all their corporate research in a new centre in Dublin.
Another interesting area in Trinity College is in vaccine development
at the department of microbiology. Among other projects is one with the
objective of developing a vaccine for mastitis.
In animal genetics research is in progress at University College,
Galway, in collaboration with the Agricultural Institute to develop transgenic
animals including fish. This work is funded by the EEC in association with
French researchers.
The Dairy Microbiology Dept., at University College Cork, and the
Agricultural Institute at Fermoy, have developed considerable expertise in the
genetics of dairy starter culture organisms: Strains of bacteriophage resistant
bacteria developed by this group are now used to produce almost all of the
50.000 tonnes of cheddar cheese produced in Ireland. Further work on the
genetic manipulation of other important dairy micro-organisms is under way.
D IAGNOSTIC T ECHNOLOGY
Ireland has much expertise in this area. The dose contacts between
the biological and clinical scientists in Ireland has been an important factor
in the development of this area of technology.
75
The major centre for research on diagnostics is in University College
Galway, where work is ongoing on solid phase immunodiagnostic
technology, and on the development of kits for various human and animal
hormone indicators.
Veterinary diagnostics is an area of particular interest because of our
large livestock population. Work at University College Galway resulted in
the development of the first animal progesterone assay to be put on the
market. This was the progesterone measuring system from Noctech Ltd. This
Irish company has produced Reprostrip, a rapid assay for progesterone.
Ireland also has a very important thoroughbred horse industry.
Research on behalf of this sector is conducted by the Irish Equine Centre, a
privately funded organisation, in association with university researchers.
This centre is currently researching indicators of stress, eg travel stress, in
performance horses with a view to developing diagnostic kits for equine
health. Diagnostic kits are also in preparation in other centres for Epstein
Barr Virus, Chlamydia and others.
B IOPHARMACOLOGY
Ireland has a large pharmaceutical and healthcare industry. To service
the needs of this industry, both for technical services and for trained staff,
Irish colleges have developed centres of expertise in several relevant areas.
Of particular interest are:
Development of in-vitro tests for pharmaceutical screening and for
toxic effects. Among the projects in progress at the moment are invitro assays for detection of drug-related specific neural tube defects,
eg spina bifida and also an assay for assessing efficiency and toxic
effects of cancer chemotherapeutic drugs. Development of novel drug
delivery methods.
MAMMALIAN REPRODUCTIVE P HYSIOLOGY
Ireland is one of the major milk and meat exporting countries in
the world and breeding of sheep and cattle is therefore of great
importance. Both the universities and the Agricultural Institute perform
research on many topics of relevance to the breeding and production of
cattle and other livestock. A topic which is of relevance to
biotechnology is the area of mammalian reproductive physiology. The
76
research group of Prof. Ian Gordon at University College Dublin, was
among the pioneers of Embryo transplantation.
Work by this group and the associated group of Dr J Sreenan at the
Agricultural Institute at Beldare, Co Galway continues on areas such as
immunological control of reproduction, embryo sex determination, oestrus
control and in-vitro fertilisation.
P LANT B IOTECHNOLOGY
The major crops of interest to Irish biotechnologists are potato,
cereals and ornamentals. Ireland has a large seed potato industry based on
exports to Mediterranean and N African countries. The majority of these
exports are two varieties which were bred at the Agricultural Institute,
Oakpark.
Forestry research focuses on the use of mycorrhizae to assist the
reafforestation of our marginal lands. Research on inoculation of
seedlings with candidate strains of mycorrhizae is underway in the Forest
and Wildlife Research Laboratory and at University College, Dublin.
Agency
National Board for Science and
Technology NBST, until late 1987
From beginning of 1988
Bio research Ireland
Industrial Development Authority, IDA
The Agricultural Institute – An Foras
Taluntais, AFT
Institute for Industrial Research and
Standard, IIRS
Role
*National S & T policy and programme
formulation: advice to government:
promotion of specific technologies,
including biotechnology and
coordination of research
Biotech activities of NBST have been
privatized. BioResearch functions as a
contract research and technology transfer
organization. Staff and mandate similar
to that of NBST.
Attraction of overseas investment,
support for Irish enterprise
Agriculture and agricultural product R&D
*Industrial Research and services;
Establishment of national standards
*These two agencies were merged in January 1988 to form
Technology Agency.
EOLAS,
the Irish Science &
The Irish National Programme for Biotechnology was jointly
developed by the NBST and the IDA.
Biotechnology Infrastructure
The major agencies responsible for the various elements of the Irish
National Programme for biotechnology are contained in the table below.
The NBST’s role within the Irish National programme was primarily
to develop national biotechnology expertise and facilities and to maximise
its application to Irish industrial and economic development.
The NBST achieved this end by:
Funding basic and precompetitive research in universities.
Promoting and assisting university-industry research co-operation.
Promoting and assisting international research co-operation.
A very important part of the programme is the improvement of
linkages between industry and researchers in Irish universities and the
development of international linkages. Irish researchers are actively
encouraged to perform research for industry in other countries, and also to
form partnerships with other EEC researchers from participation in EEC
research programmes.
77
78
The process of linking university researchers and industry has been
one of the major activities of the NBST. To this end a newsletter, Irish
Biotech News’ was published and distributed widely in Ireland and abroad.
Mechanisms for Biotechnology Promotion
As mechanisms for co-operation are of specific interest to participants
in SOBELA, it may be useful to point out some of those used in Ireland:
1. Publication of a newsletter – Irish Biotech News, which is
distributed free of charge to both industry and researchers and
highlights co-operative opportunities.
2. Running of seminars and workshops on topics of common interest.
For each chosen topic both researchers and relevant industry
representatives are specifically invited so as to encourage contacts.
3. Grants of up to 50% of the cost of university/industry co-operative
research, are made available.
4. Funding assistance is given towards the employment of scientists and
technologists by companies with a low level of technical employees.
put a very high priority on international co-operation in
research. Irish researchers have a particular problem in that our island
position makes the travel necessary for co-operation more costly than on
mainland Europe. To alleviate this, the NBST provide assistance towards
visits by researchers to other research centres. This mechanism proved
highly successful in developing collaborative research teams for
applications to EEC research programmes. NBST also strongly promoted
involvement in EEC and in other international programmes as a means of
developing contacts and collaboration. We have also formed scientific and
cultural exchange agreements with many countries.
NBST
Recent Developments
In 1988 many of the activities of the NBST were merged with those of
the IIRS to from EOLAS – the Irish Science and Technology Agency. EOLAS
is geared to generating income for the state. BioResearch Ireland represents
biotechnology activities within EOLAS, and is focused on three national
centres:
National Cell & Tissue Culture Centre
National Food Biotechnology Centre
National Diagnostics Centre
The National Cell and Tissue Culture Centre is located in the
National Institute for Higher Education, Dublin, which was set up in 1980.
The focus of work is monoclonal antibody production and all aspects of
animal cell culture, including toxicity testing applications. Contract
research is going on with a number of companies in Europe and elsewhere.
The National Food Biotechnology Centre is located in University
College Cork. Genetically manipulated organisms are developed to enhance
food bioprocessing and flavours. Cheese microbiology is a particular strength.
The National Diagnostics Centre, located at University College,
Galway joins many skill bases to develop innovative diagnostics, including
DNA probes. Custom synthesis of oligonucleotides is a feature of this
facility’s competence that could be of interest for outside clients.
Regulation of Biotechnology
A National Recombinant DNA Committee advises planning authorities and
others on the safety of genetically engineered organisms used in the state. The
committee is composed of experts, and representatives of the public, unions,
industry and government. The guidelines of the National Institute of Health, NIH,
in the USA have been adopted by the committee with some modification.
79
80
The investment made in this first round of funding was judged
inadequate, but none the less it demonstrated Italy’s commitment to meeting
the levels of R&D expenditure sustained by other developed countries.
1.7. ITALY
Carmello Iacobello
Recently there have been major changes in the organisation of Italian
biotechnology. In 1985 biotechnology R&D was fragmented without real
direction or co-ordination.. No national priorities had been defined.
Most of the nation’s biotechnology programmes were at that time focused
on human health and supported by the National Research Council, CNR.
Table 1.. Finalised Biotechnology Projects 1985 National Research Council
Council.
Genetic Engineering and the molecular basis of inherited disease
Infectious diseases
Oncology
Biomedical technology
Improvement of agricultural production
Fine and secondary chemistry
This initial set of projects gave rise to competence in several key
aspects of biotechnology, such as monoclonal antibody production and
molecular recognition. Significant short term advances were made in the
area of gene manipulation and the production of recombinant products.
In the context of the fine chemistry projects
jects several advances in
enzymology were funded, and in the domain of agriculture some
rationalisation of modern plant genetics was undertaken at national level.
Figure 1 compares the rate of growth of R&D expenditure as a
%age of GNP up to 1984. The data are derived from a report of the Italian
Chemistry Federation, Federichimica, on biotechnology entitled ‘Le
Biotecnologie in Italia: un opportunita di sviluppo industriale’. Milano 1986.
In 1985 a National Biotechnology Committee had been created,
supported by the Committee for Development and Innovation in the
Chemical Industry Federation. These bodies recommended the pursual of a
National Biotechnology Policy, charged with organising, funding and
directing programmes.
The National Programme represented a logical development, for
24% of Italy’s revenues are based on organic or biological products with
a 1984 value of 112 billion US$ (see Figure 2). This percentage is higher
than for other countries and illustrates why biotechnology is of such keen
interest; several key market areas of relevance to Italian industry are affected.
The areas illustrated in the following diagrams have several
common features:
They are big markets with potential for large expenditure;
They are characterised by imported products;
SMEs have a high profile in this market. They need a common
development policy.
The Italian health care market was worth US$6 billion in 1984, about
35% of that spending going on diagnostics, pharmaceuticals and biomedicals.
By 1990 this area could be 25-35% dependent on biotechnology products.
Agriculture accounts for total invoices of US$32 billion, spent mostly
on animal breeding, cereals and vegetables. Consumption increases are
causing an import boom. The animal feed sector in particular, worth US$26
billion (1984) is characterised by a significant excess of imports over exports.
81
82
% of production from organic sources in respect to the global internal product (1984)
Countries
Close-up of sectors in Italy (1984)
%
Sectors
Italy
24%*
U. K
22%
U.S.A
20%
France
Germany
*24% = 112,000 million US$
19%
18%
%
– Agriculture
– Extractive
– Manufacturing
Feed
Texture
Wood
Chemistry
Paper
Others
– Health
5.1
1.0
13.2
2.4
3.3
1.0
2.9
0.7
2.9
4.7
Total
24.0
Fig. 2. Comparison between various industrialized countries concerning their percentual
production from organic sources. From the report of Italian Chemistry Federation
‘FEDERCHIMICA’ on Biotechnology ‘Le Biotechnologie in Italia: un’opportunità di
sviluppo industriale’, Milano 1986.
Several factors influence this:
Feed habits orient towards a strong feed industrialisation (with low
cost);
Trend to ‘natural feed’ with high quality food from direct agricultural
sources and wide availability throughout the year (with high cost).
Biotechnology might solve the problem by providing high quality
food at low prices. Production and storage technologies might also be
favourably influenced.
Ecological considerations will play an increasingly important role in
the industrialised nations. The processing and recovery of industrial and
agricultural wastes is a market worth perhaps US$15 billion within a decade.
Lack of ecological surveillance could precipitate high costs in both social
and economic terms.
Ecologically relevant companies have increased by more than 75% in
number since 1980.
83
In the Chemicals sector the global market for Italian products was
estimated at US$26 billion. This potential is compromised however, by a
massive dependence on imported products.
All sectors of industrial activity are therefore open to the influence of
biotechnology. An industrial representative committee has considered the
following theoretical areas of application.
40% of biotech products would be new, not realisable by existing
technologies.
60% of biotech products could represent the consequence of
improvements to existing processes.
70% of ideas generated could be realised in the short to medium
term that is up to 5 years from now.
In 1985, in response to these ideas the National Research Council,
created a Task Force to mobilise activity in well focused research
areas. Focused on CNR and university laboratories the resulting programme:
Strategic Project, Advanced Technology in Biology, was divided into three
major subprogrammes:
Biotechnologies
Agro-industrial technologies
Aquaculture
CNR,
Table 2. National Research Council:
Strategic Project Innovative Technologies in Biology’ (1986-1987)
Funding: US$2.1 million
Subprojects:
1. Biotechnologies
Enzymology, natural or modified enzymes
Agro-industrial biotechnologies
Oligonucleotide synthesis and molecular probes
Cellular carriers
Biosensors
2. Agrotechnologies
Cultivated plant technologies
Molecular and biological control of parasites and abiotic stresses
Models of agroecosystem productivity
3. Aquaculture
Artificial reproduction and genetic improvement in fish breeding
Reproduction and breeding of new fish species
Breeding of molluscs
84
In the first two years the budget for this programme was low, only
US$2.1 million, but the idea was to orientate a number of research groups to just
a few well defined technologies.
Following on from this programme is the: Special Project:
Biotechnology and Bioinstrumentation, with funding of US$68 million over
the five year period, 1987-1991. This programme will focus on precompetitive
aspects of biomedical and chemical areas. Addition of important new
subprogrammes in vaccines, cell culture and transplantation biology is a
feature. The CNR will involve universities and research institutes in the
programme.
Table 3. National Research Council:
Special Project ‘Biotechnology and Bioinstrumentation’ (1987-1991)
Funding: US$68 million/5 years
Subprojects
1. Molecular and Cellular Engineering
2. Innovative vaccines and bio-diagnostics
3. Biosensors, cellular bioreactors
4. Applied biotechnologies: cell culture, organ transplants
5. Bio-drugs
6. Bio-instrumentation
Table 4. Ministry of Scientific and Technology:
National Project Advanced Biotechnologies’ (1988-1992)
Funding: US$308 million/5 years
1. Medicine and veterinary areas
Diagnostics
Plasma proteins
Fibrinolytics enzymes
Biological response modulators
Immunotherapeutics
2. Chemistry, Energy and Environment
Biocatalysis
Biopolymers
Biological control of pollution
3.
Agriculture and Food
New plants
Micro-organisms
Animal husbandry
Food bio-conversion
Food diagnosis
85
A third major programme designed to stimulate industrial
competitivity and innovation through government support, is entitled:
National Programme, ‘Advanced Biotechnologies’, funded by the Ministry
of Scientific Research and Technology. This programme envisages
expenditure totaling US$308 million over the five year period to 1992.
Table 5. Nonmedical applications of biotechnology.
Chemistry, energy and environment
A) New enzymes
B) Innovation on bio-conversion and enzyme catalysis
C) Polysaccharides from natural sources
D) Control and recovery of environments
E) Bioprocessing of minerals
Agriculture and Feed
A) In vitro plant generation
B) Introduction and expression in plants of exogenous genes
C) Plant nitrogen metabolism
D) Biological defence of plants
E) Improvement of growth and nutritional properties of breeding animals
F) Enzymes for feed industry
G) Treatment of agricultural wastes
H) Control of food safety
In Table 5, two of the areas considered above are examined in closer
detail. There is broad accord with the aims expressed by the European
Commission, particularly with regard to the stimulation of agro-industrial
development.
The Italian response to the recent Commission ‘Call for Expressions
of Interest’ on the theme, ‘Stimulation of Agro-Industrial Development’,
was most encouraging (see Fig 3). Some 70% of the Italian ‘expressions’
were from industrial organisations (see Fig 4).
86
Other public programmes with an element of biotechnology are
summarised in Table 6.
Agro-industrial development – Results of call for interest
In the planning stage is an agricultural programme with a provisional
budget of several hundred million US$. Focus will be on crop production,
animal breeding and adding value to agricultural by-products.
Total = 856 interest forms
Cost + 580 millions U.S. $
Table 6. Other publicly financed programmes in biotechnology
Programme
Focus
Value US$
million
CNR Special Projects:
Fine chemistry:
Genetic engineering:
Fig. 3. Results of call for interest concerning the ‘Stimulation
Stimulation of Agro
Agro-Industrial
Development’ from EEC expressed as national
onal percentual of the total responses. From
EEC document CUBE-XII/233/87.
Industry Interest
Ministry of Science and
Technology, National
Programmes:
Technology in oncology
Pharmaceuticals:
Biologically active products
rDNA technology vs genetic disease
Monoclonal antibodies and DNA
probes
Targeting of cytotoxic drugs
D
IRL
Total = 266 (31%) forms
Cost = 318 Millions U.S.$
P
UK
0%
50%
100%
Fig. 4. Industry interest for stimulation of agro-industrial
industrial development. Results are
expressed as percentual of total responses from each country. From eec doc
document
cube-xii/233/87
87
14
4
In Figure 5 the present state of national funding programmes in
biotechnology is recapitulated. The overall commitment of funds is seen to
exceed US$430 million over the present five year period. This major funding
is intended to bridge the gap between industrial innovation and academic
research, so strengthening the Italian presence in this key area of technology.
DK
L
18
23
88
Public fundings for Biotechnologies
1.8. THE NETHERLANDS
Henk C. van der Plas
In September 1984 Professor Schilperport, then Chairman of the
Programme Committee on Biotechnology, PCB, suggested that in the 1990s the
Netherlands might be the biotechnology delta of Europe. Is that fiction or reality?
The Netherlands posses an industrial base of about 100 biotechnology
firms, together providing an R&D potential of 1,100 manyears (in 1985).
Sales of traditional biotechnology products in the dairy, brewery and
antibiotics industries accounted for sales of about US$4 billion. New
products such as recombinant vaccines and diagnostics based on
monoclonal antibody technology are contributing to 1987 sales of about
US$40 million.
Fig. 5. Comparison between two periods of public fundings to
biotechnology in Italy. PN MRST: National Program from Ministry of
Scientific Research and Technology. CNR PF: Finalized Project from
National Research Council.
A few major companies dominate biotechnology in the Netherlands.
These have a base in traditional biotechnology and have rapidly included
new technology in their ranges of competence. Many, much smaller
companies have emerged recently, partly because of the relatively easy
access to investment capital.
Figure 1 summarises the scope for biotechnology R&D in the
Netherlands. The role of the major companies is clear.
Because of the small size of the country and the initiative of the
government in pushing activities in biotechnology, there exists a solid
network of contact and communication among all Dutch biotechnologists,
in industrial, university or government laboratories.
The standard of excellence in Dutch universities is among the highest
in Europe, and although there was considerable displeasure some 7 years
ago when the government first sought to stimulate a productive orientation,
almost all would now admit that the scheme has been successful.
89
90
Composition of industrial base 1985 a total of 1100
manyears was commited to biotechnology R&D
DSM, CCA, Avebe,
Heineken, Naarden carry
out 7-30 man-years R&D
the middle group
90 companies carrying
out R&D constitute the
rest
GIST, BROCADES, AKZO,
Unilever- The big 4
contribute 100-400
manyear each,
representing 80% of
industrial R&D
Fig. 1. Scope for biotechnology R&D in the Netherlands
The small size of the country cannot hide the fact that it plays host to
some of the more prominent multinationals. The financial power of big
companies, combined with experience and marketing know how has made
it possible to exploit the opportunities in biotechnology.
Small is effective for the Netherlands. Communications are no
problem as all locations are geographically close.
The government has made biotechnology a priority area, not only
because of the solid industrial base, but also because biotechnology
provides fast growing market opportunities in many industrial sectors.
The Role of the Government
The government launched its Innovation-Oriented Biotechnology
Research Programme in 1981. This formed part of a series of similar such
91
programmes in a number of strategically critical areas including:
membranes, polymers, composites, carbohydrates, engineering ceramics
etc. The primary goal of these innovation oriented research programmes,
IOPs, is to stimulate research in universities and institutes. The goal is three
pronged, seeking:
to stimulate research.
to structure the knowledge infrastructure through division of tasks,
co-operation and market orientation.
to set up a communications network.
Let me explain these three points. Stimulation of biotechnological
research at universities and institutes is being accomplished by provision of
an extra US$20 million between 1981 and 1990. The money is shared out by
a high level body, the Advisory Committee on Biotechnology, ACB, which,
although government appointed, works at arm’s length from the
government. Its membership includes representatives of both industry and
research institutes. The indirect, co-ordinating, effect of this extra financial
stimulation is, in my opinion, even greater than the direct impact.
The Advisory Committee on Biotechnology seeks to realise the entire
threefold goal simultaneously. As in some countries, government funded
university research in the Netherlands is being trimmed, owing to budget
constraints. The division of tasks is therefore an indispensable element for
structuring the knowledge infrastructure (e.g. to avoid overlap).
Biotechnology is a multidisciplinary science. Co-operation between
research teams is a sheer necessity, because only integration of knowledge
can produce practical applications. The third element of restructuring the
knowledge infrastructure, finally, is more market orientation. Extensive
consultation with industry was found to be a simple and effective way of
learning exactly what the market needs.
An inventory of the wishes and needs of industry, as regards both research
objectives and research teams, served as a basis for this industrial orientation. The
inventory was made through confidential interviews, the results of which were
generalised. This guaranteed an open industrial orientation.
The third goal, that of building up a communications network, is vital
for the rapid growth of a new technology, which cannot develop without
dose co-operation between everyone concerned.
92
Central to the IOP network is the Advisory Committee on
Biotechnology, ACB, which co-ordinates the overall stimulation of the four
sub-programmes on Biotechnology under the supervision of four separate
Programme Committees, PCs. Each of the four PCs receives money from
the Ministry most closely involved.
The ACB together with the four Programme Committees has also
succeeded in creating the conditions for good fines of communication
between research institutes, industry (including investors) and government.
In the first stage of the IOP, from 1981 through to 1984, financial
stimulation was used to raise the level of biotechnological research on a broad
scale, while building up a communications network. At the same time inventories
were taken to determine the direction of the infrastructure structuring.
In the second stage from 1985 to 1990, structuring is being selectively
programmed and anchored in the infrastructure, so that industry will be able
to continue making optimal use of the government funded knowledge
infrastructure after the programme has ended.
The following tables show the range of activities encountered in
government funded institutes and universities.
93
Table 1. The Major University Biotechnology Centres in the Netherlands.
Centre
Activity
BDL, Biotechnology Delft-Leiden
Incomplete oxidations
(Technical University Delft & State
Plant cell biotechnology
University Leiden)
Yeast physiology/genetics
Environmental biotechnology control
Bioreactor design and downstream
processing
Agricultural University Wageningen
Biocatalysts
Food and animal feeds
Waste and environment
Plant cells
Animal cells
BCA, Biotechnolog Centre
Opimisation of product formation by
Amsterdan (Free Universit
micro-organisms
Amsterdam & University of
(yeast & prokaryotes)
Amsterdam)
Plant biotechnology
Monoclonal antibody production
Enzymology
State University Utrecht
Vaccines
Peptide and polypeptide hormones
Monoclonal antibodies
State University Groningen
Fine chemicals and stereo specific
reactions
Development of host-vector systems for
industrial micro-organisms
Biological oxidation, biodegradation of
waste
Chemical
Optimisation of dairy micro-organisms
94
Table 2 Some of the Important Biotechnology Research Institutes in the
Netherlands
Institute
Activity
Plant Biotechnology
Wageningen: SVP, ITAL
ITAL
IVT
IPO, IVT
Baarn:
CBS
Agroprocess Biotechnology
Wageningen: Sprengen-IBVL
IMAG
Ede:
Groningen:
Zeist:
NIZO
NIKO
TNO
Animal Cell Technology
Lelystad:
CDI
IVVO
Wageningen:
ITAL
Zeist:
IVO
Medical Biotechnology
Amsterdam:
CLB
NKI
Bilthoven:
Rijswijk:
RIVM
TNO
Genetic engineering for plant breeding
Secondary metabolite production for high grade
chemicals
Horticulture
Disease and pest resistance
Central Bureau for Mycology
Bilthoven:
Lelystad:
TNO
RIVM
RIZA
Since 1983 the Dutch government has encouraged industry to
participate in ambitious R&D programmes. Two forms of subsidy have
backed up this encouragement.
the INSTIR subsidy scheme
case by case assessment
INovation STImulation Regulation,
support for R&D. Given the massive cost
is a scheme which offers wage
of wages in modern industry this
incentive dramatically lowers cost thresholds and has been provided for a
number of promising technologies, including biotechnology.
Processing of waste flows
Treatment of manure
Dairy production and processing
Carbohydrates
Although university collaboration was not a precondition of these
subsidies, it is a testimony to the establishment of the communications
infrastructure that, in practice most projects were carried out in
collaboration with universities or institutes.
Food and animal feeds (incl. biocatalysus and
bioprocess technology)
The recent economic upturn has made R&D financing much easier for
companies, who are now less in need of government support. Since 1987 the
Dutch government provides incentives only for technologies in which the
support policy results in the highest added value.
Vaccine and diagnostics development
Livestock feeding/nutrition
Malaria control by insect genectics
Animal production
Blood/blood factor research tissue culture
Cancer research
Human vaccines and other biological
Monoclonal antibodies for
diagnosis/therapy/research rDNA technology
Environmental Biotechnology
Amsterdam/Delft:
INDUSTRIAL B IOTECHNOLOGY P OLICY
Fermentation and bioprocessing recycling,
purification, membrane technology
Microbiological soil and water treatment
Waste water research
95
Biotechnology is one of the four high tech areas that continues to
benefit from public support. The technology policy enabling the knowledge
infrastructure through the IOP is being followed up in the form of a
programme policy concerned directly with industry.
At this stage the goal is to increase the number of firms engaged in
new biotechnology operations from 10 or 20 to 100! More than 100
potentially promising firms that we now have are being prevented from
achieving high-tech production in the near future, not so much by lack of
money, but by a low level of in-house research activity.
Subsidies do not play major role in the government’s programme
policy, although they do perform a valuable supportive role. The
programme for the 100 companies target covers a number of synergic and
mutually complementary activities.
96
INFORMATION AND CONTACT
OPTIMISING THE CHANCES FOR SUCCESS
A vital factor in pulling firms across the threshold towards new
technologies is information. This part of the programme is already in full
swing, with the publication of booklets and a biotechnology magazine in
Dutch. Printed information does not suffice. Personal contacts through
consultants paid for by the Economic Affairs Ministry often produce better
results. The consultant acts as a broker between industry, the knowledge
infrastructure and government.
IOP B IOTECHNOLOGY
Already discussed in the earlier part of this presentation.
STIMULATION OF INDUSTRIAL R&D P ROJECTS
An important criterium for selection is co-operation with a university
or institutional research group. This industrial stimulation is therefore
closely linked with the IOP stimulation.
ESTABLISHMENT OF NEW COMPANIES
Can foreign companies be persuaded to set up in the Netherlands, as
a consequence of providing the appropriate infrastructure? We have been
successful, as the establishment of subsidiaries of the American
biotechnology firms, Centocor, Mogen International, Promega and recently
EuroCetus demonstrates.
EDUCATION
Without suitably skilled manpower, no innovation is possible. We are
busy setting up a postgraduate training facility for biotechnology engineers,
a joint initiative of Delft and Leiden.
INTERNATIONAL CO -OPERATION
For a small country like the Netherlands, cross frontier co-operation is
important, particularly within the context of the European Community, EC,
and EUREKA. Non-European collaboration also receives dose attention from
the government, particularly the third world countries. The Netherlands have
initiated biotechnology collaborations with Indonesia, India and Thailand.
97
General policy actions relating to the approval of biotechnology
products, patent matters, supplies of cheap raw materials for the
fermentation industry and last but not least – social acceptance.
The Dutch government is working for industrial innovation in
biotechnology along these lines.
W HAT H AS B EEN ACHIEVED ?
A number of products have emerged from the Dutch Biotechnology
initiatives. The following are just a sample that illustrates the breadth and
potential of the Dutch biotechnology enterprise.
Anaerobic purification of waste water: a co-operation between
universities, TNO and Gist-Brocades
Development of a vaccine against diarrhea in calves and piglets: a
co-operation between RIVM and Amsterdam University.
Pregnancy test using monoclonal antibodies: Organon
Preparation of D I L amino acids by enzymatic separation of D, L
mixtures: Dutch States Mines, DSM.
Production of aspartame: DSM, Toyo Soda
Biofilters for air filtration, production of chymosin with rDNA
technology: Gist-Brocades, NIZO
Many other products and processes are well on the way to realisation.
The last table gives evidence to support the assertion that growth in
biotechnology will be gradual, but steady. At this point I return to the claim
that The Netherlands might become a Biotechnology Delta in the 1990s. It
is still premature to say that this is more than fiction, but we are working
hard to create a really strong base for industrial biotechnology in the next
decade. We are full of confidence and so far, if I may say so, we have not
been unsuccessful!
I hope this introduction to Dutch biotechnology has roused your
interest and that it may lead to the next step of entering into dose cooperation with Dutch partners. The Netherlands is ready for it.
98
For anyone wishing to learn more about Dutch biotechnology, a
highly informative and illustrative brochure can be ordered, as well as a list
of names and addresses of Dutch firms and institutes active in the field.
Table 3 Biotechnology Sales for Various Industries: (figures in millions of Guilders)
Total
Biotechnology sales
Industrial sector
1982
1985
1990
1995
Fine Chemicals Human & Veterinary
6500
460
555
655
Health Care
2500
750
1000
1350
Food and Beverages
64000
8500
9400
10800
Equipments and Instrumentation
13000
275
310
350
Engineering Contractors
1500
90
160
210
Source: CIVI
1.9. PORTUGAL
Julio Novais
In Portugal, biotechnology has become integrated into the traditional
biology dependent industries. Microbiology and enzymology are now
finding new applications. Many scientists have returned from training and
employment overseas. This new resource of largely European trained scientists
is now helping to create new poles of academic and industrial excellence.
The promise of biotechnology is being hindered in Portugal by the
lack of entrepreneurial tradition. Human potential and favourable political
conditions do not alone create new industries and economic development.
The government is sympathetic and started the implementation of a
Mobilisation Programme in 1987. Funding levels for biotechnology have
increased each year and are being complemented by funds from the
European Commission and with A.I.D.
This presentation attempts to identify the impact of biotechnology
on Portuguese industry and agriculture as well as its potential in
research and education.
INDUSTRY
The industries involving biotechnology can be divided into two
sectors, one more traditional and the other of a more modern kind which
can be situated in the post antibiotic era.
In the first case, it is justifiable to start by referring to the wine
industry, which has acquired great importance both internally and for export
income. Port, Madeira and some Rosé wines contribute most.
The fruits of yeast research are now being enjoyed. Strain selection
and slow fermentation conditions are being optimised so as to minimise
undesirable contamination or side products. The sparkling wine industry is
exploring the possibilities offered by immobilised yeast cells and
continuous fermentation.
99
100
In the cheese industry microbial enzymes are used in large scale
production, but the best cheeses, called Serra, are still produced
traditionally. Cardoon flowers are immersed in sheeps milk, a process prone
to contamination and quality variation. Family production methods are
being studied in the laboratory so as to identify proteases. It is hoped that it
may be possible to produce cheese ‘in vitro’ with suspended and
immobilised cardoon cells.
The old olive oil industry could be improved with better extraction
processes and regeneration of the older plantations. New technologies such
as micropropagation could play a useful role.
The beer industry has achieved a sophisticated understanding and
control of the processes of malting and fermentation.
Antibiotic production is a significant export earner, with more than
90% exported. The major products include: penicillin, tetracycline,
oxytetracycline, erythromycin, gentamycin and ampicillin.
A new ampicillin process was developed in Portugal, whereby 6aminopenicillinic acid was formed by passing penicillin through novel
bioreactors containing immobilised penicillin acylase. The technology has
been successfully exported.
The fine chemicals industry carries out R&D, often in collaboration
with university laboratories. Products have included steroids and some
diagnostic kits.
Baker’s yeast is produced at two locations, while glucose and
glucose/fructose syrups are obtained with enzymatic processes.
Alcohol factories depend upon imported molasses (some 15%
produced domestically). This traditional industry is now moving towards an
incorporation of the new biotechnologies.
Environmental considerations have not been overlooked. Several
wastewater treatment plants have been constructed using a variety of
technologies: activated sludge, percolating filters and a variety of ponds. Several
cattle and poultry raising installations have built tanks for anaerobic digestion,
using the resultant biogas for ambient heating or electrical energy production.
101
AGRICULTURE
Portuguese agriculture is a very traditional discipline and the only
biotechnological input has been from classical genetics. In the future
biotechnology will affect agriculture in two ways. Firstly, the fruits of
research will influence the growth and multiplication of plants, possibly by
species improvement by gene transfer and classical hybridisation etc. The
sum of many developments in Nitrogen fixation, in vitro propagation and so
on might radically modify the culture of a given region. Already some
hybrid cereals have dramatically improved the productivity of some
regions. In vitro propagation has so far been applied only to high value
decorative plants and exotic fruits. Many technologies are unexploited, for
example the knowledge of coffee developed in former colonies.
The second major influence may come about when agriculture is in a
position to provide industrial raw materiais. The introduction of new
cultures or the modification of old ones may bring about changes. At the
moment trials are underway with an inulin producing Jerusalem artichoke.
Suitable for fructose, or by fermentation, alcohol production this could
become both a food and energy source.
Native biological resources are not overlooked. Plants of the semi
arid interior might be used to produce commercial quantities of lipids from
marginal lands. Euphorbia is presently being studied as a candidate for
exploitation.
RESEARCH
In recent years there has been an important increase in biotechnology
research. Little has yet emerged from this new development. In traditional
areas such as yeast physiology and fermentation, Portuguese scientists have
established a high standard of excellence. Fields of application would
include yield improvement and alternative methods of fermentation product
extraction, so as to reduce the energy costs of distillation.
Immobilised enzymes and micro-organisms are quite routine
applications in the fields of antibiotic production and sparkling wine
manufacture.
102
Plant cell culture has yielded important developments in the areas of
callus production, micropropagation and suspended cell culture. Other
applications are in development.
In the area of environmental biotechnology a town of 13.000
population is successfully demonstrating the use of high photosynthetic rate
ponds for sewage treatment.
At least three of the nation’s research centres have been looking at
the technologies of fermentation and down stream processing. Purification
and separation of fermentation products using ultrafiltration membranes,
and supercritical extraction of natural products exemplify this interest.
The bio-conversion of energy is being studied by groups whose focus
is on energy mediating enzymes such as the hydrogenases. In vitro
reconstitution of such activity could yield commercial benefits.
Other small groups are looking at genetic engineering, immunology,
virology, monoclonal antibodies, etc.
Most research is carried out in university laboratories and public and
private institutes. Industrial concerns only rarely have established an R&D
competence, relying instead on outside agencies. This must change if
industry is to face a sound future.
An Institute of Chemical and Biological Technologies is being
commissioned with the purpose of establishing links between
biotechnology, agriculture and the agro-food industries.
EDUCATION
Several new courses have been inaugurated to train graduates in the
skills required by tomorrow’s institutional and industrial needs. The New
University of Lisbon launched an Applied Chemistry course with a strong
biotechnology component. In the Technical University of Lisbon, the
Instituto Superior Técnico, a biotechnology course is taught during the five
year Chemical Engineering degree. In Oporto a food engineering course
was started four years ago within a Faculty of Biotechnology.
LINKS WITH LATIN AMERICA
Portugal has a long standing tradition of openness to the outside world, a
consequence of the past colonial tradition and associated migrations.
Brazil and Portugal have particularly dose ties, resulting from a
common history over several centuries and a common language. At present
high level talks are aimed specifically at creating a collaborative
relationship in the field of biotechnology. Joint workshops have been held,
with a view to establishing common programmes.
One type of link that may develop between Portugal and Latin
America involves technology transfer from biotechnology using industries.
A new antibiotics factory in Brazil, CIBRAN was designed in Portugal and
at least initially was dependent upon Portuguese technology.
Portugal's interest in fermentation and downstream processing,
alcohol and biocatalysis may be of particular interest. Support for
developing these technologies has come from the European Commission.
Tropical agriculture, pest control and disease are points of common
interest and expertise with a potential for fruitful co-operation.
Educational links are particularly favoured with Brazil. Portuguese
universities receive many Brazilian students onto their M.Sc. courses and
are willing to accept Spanish or Portuguese speakers onto Ph.D. degrees.
Both Latin American and Portuguese workers have shown the willingness
to travei so as to learn or teach new technology.
The mobility of research workers and teachers seems of fundamental
importance if Portugal and Latin America are to keep pace with modern
developments. It is essential to create bridges between Europe and Latin
America. The funding of a programme to this end would be of great value.
At postgraduate level two courses exist, at the New University of
Lisbon, in conjunction with the Gulbenkian foundation and at the Instituto
Superior Técnico.
103
104
Annex: List of Organisations Active in Biotechnology in Portugal
Plant Genetics:
EAN
Estação de Melhoramento de Plantas de Elvas
Industry
Antibiotics
Cipan
Soc. Port. Leveduras Selecionadas
Fine Chemicals:
Quatrum
Hovione
France-Farmaceutica
Baker’s Yeast:
Propam
Soc. Port. Leveduras Sellecionadas
Starch:
Copam
Wine Research:
ISA
Breweries:
Centralcer
Unicer
Aqualculture:
ICBAS
INIP
Monoclonal Antibodies:
IGC
ICBAS
Lignocellulose degradation:
ISA
LNETI
Biogas Production:
LNETI
UNL
Plant Micropropagation
Alcohol Fermentation:
Environmental Biotechnology:
Universidade de Tras-Os-Montes e Alto Douro
Fine Chemicals, Diagnostic kits:
Food Biotechnology:
LNETI
IST
LNETI
Escola Superior de Biotechnologia, Porto
Instituto Superior de Agronomia
Estação Vitivinícola Nacional
In Vitro Plants
Research
Yeasts:
IGC
Instituto Gulbenkian de Ciencia, IGC
Universidade do Minho
Instituto Superior Técnico, IST
Faculdade de Engenharia da Universidade do Porto
Laboratório Nacional de Engenharia e Tecnologia
Industrial, LNETI
Universidade Nova de Lisboa, UNL
IST
Universidade de Aveiro
Virology:
IGC
Human Biotechnolgy:
Instituto Nacional de Saúde Pública
Animal Biotechnology:
Escola Superior de Medicina Veterinária
Laboratório Nacional de Investigação Veterinária
Immunology:
Universidade de Coimbra
LNETI
Immobilised Biotacalysts:
IST
Algal Biotechnology:
Instituto Nacional de Investigação das Pescas, INIP
Universidade de Coimbra
LNETI
Further information on Portuguese biotechnology centres can be
obtained from the speaker or from the following institutions:
Energy from Biomass:
LNETI
JNICT – Junta Nacional de Investigação Científica e Tecnológica, Av. D,
Carlos I, 126-1o, 1200 LISBOA, PORTUGAL
Bioreactor design and Downstream
Processing:
FEUP
IST
UNL
Sociedade Portuguesa de Biotecnologia, c/o Instituto Superior Técnico,
1096 LISBOA CODEX, PORTUGAL
Hydrogen and Methane Production:
UNL
IST
Genetic Engineering
IGC
Instituto de Ciencias Biomedicas, ICBAS
Plant Cell Biotechnology
Faculdade de Ciencias Lisboa, FCL
Estação Agronômica Nacional, EAN
Tropical Plants:
Centro de Investigações do Café
EAN
105
106
STAFF T RAINING
1.10. SPAIN
Armando Albert
Spain supports over 100 research fellows. A further 80 + fellows have
spent at least one year in foreign centres.
CENTRO N ACIONAL DE B IOTECNOLOGIA, CNB
Biotechnology, understood as the application of the principles of science
and engineering to the treatment of materials by means of biological agents, for
the production of goods and services, comprises a wide field of study.
Initiated in 1987 this centre should become fully operational this year,
representing a total investment of about us$25 million. Director, Michael
Parkhouse has been appointed and recruitment of other senior staff is going on.
The economic and social importance is now unquestionable,
especially if it is understood that in our country the production value of the
potential users amounts to some 15% of the Gross Domestic Product.
Fifty research projects are being financed in public sector
laboratories, and a further 10 projects involving companies, with a total
budget of about US$8 million.
Mobilising Programme
The research projects fall into the area of application orientated basic
research. 18 studies are ongoing, 8 in genetic engineering, 9 in human and
animal health, 9 in chemical and agro-food industry, 9 in Agriculture and 5
in biomass and pollution control.
Spain has a scientific community capable of incorporating
biotechnology into its production systems, and into an improvement of its
services. For this a series of objectives have been defined and the
necessary economic resources for the Biotechnology Mobilising
Programme have been made available. This Programme was initiated by
the government in response to the perceived gap in the organisation and
execution of biotechnology research and application. The situation was
explained in the volume: ‘Programa Movilizador de Biotecnologia’,
published by the Ministry of Science and Education in Rine 1985.
So far the execution of the Mobilising Programme has been
satisfactory, with objectives being attained. The state has made funds
available and no major contradictions in proposals and financial realities
have emerged.
Present Situation of the Biotechnology Sector
More than 250 groups are working on biotechnology in the public
sector (universities and government research laboratories) and nearly 50
firms have expressed an interest in biotechnology R&D. The situation
indicates sufficient activity to generate a biotechnological ‘critical mass’ in
the near future. The response to the Mobilising Programme has been
encouraging and early results are promising.
107
Industrial projects focus upon aspects of human and animal health,
the chemical industry and the food industry. The Centre for the
Development of Industrial Technology, CDTI, has taken up the
responsibility of supporting 20 R&D programmes with a total value of about
US$30 million.
The conclusion of the Mobilising Programme has stimulated the view
that it is necessary to continue and increase efforts in this area with a R&D
National Programme in Biotechnology, along the lines indicated below.
Planned Actions
The following major themes encapsulate the National Programme.
1. Human Resources – Staff Training
The Mobilisation Programme confirmed the need to increase efforts
in training. During the five year period of the National Programme it is
proposed to train a further 225 biotechnology PhDs, and to send 100 to 150
scientists to foreign centres of excellence, with a view to covering
deficiencies in areas such as: biochemical engineering, downstream
processing, cell culture, etc.
108
This effort must be accompanied by the establishment of relevant
courses for specialist engineers and technicians. It is anticipated that the
National Biotechnology Centre will play a decisive role in this training effort.
At least 100 scientists are going to be recruited into the public sector
so as to reinforce Spanish biotechnology. At least 35 of these new posts will
be in the CNB.
2. Instrumentation and Utilities
This part of the programme will concentrate on two actions:
Support for the acquisition of equipment and instruments of middle
to high price for the CNB and other public sector laboratories.
Creation of regional centres of excellence in biotechnology,
associated with the CNB and other public institutes in their scientific
environment. Financing is expected to be a mixture of national and
regional. The creation of at least five such regional centres is foreseen.
3. Financing of R&D Projects
According to needs identified and the scientific and technological
possibilities, research and technology development will be supported, with
emphasis on the following priority areas:
a)
b)
c)
d)
e)
basic research in biotechnology (3 areas)
agro food and agro-industrial aspects (6 areas)
health (4 areas)
industrial technology (5 areas)
biodegradation and pollution control (3 areas)
Ninety projects in universities and public laboratories, and between
35 and 40 concerted R&D projects are expected to be partly financed by
industry, over a three year period within the five years of the programme.
4. International Relations
The participation of public research centres in European Community
programmes will be actively supported. Special fellowship programmes
will be established for graduates speaking Spanish or from the same
geographical area. In the CITED-D, the Research Programme related to the
109
500th anniversary of the discovery of America, a number of projects in
biotechnology have been established with Latin American collaborators.
5. National Biotechnology Centre
The creation of a National Biotechnology Centre was one of the
specific objectives of the Biotechnology Mobilising Programme. Designed
to house some 300-350 scientists this Centre of Excellence will require solid
support during the launch phase. Such support will be provided by the
Mobilising Programme.
Such is the significance of this venture that it is best considered apart
from other aspects of the Mobilising Programme, although of course it will
interact with all parts of that Programme. Staff Training
STAFF TRAINING
The Centre should be able to commence training of high calibre staff
by the middle of 1989, through the organisation of courses and specialised
workshops. A graduate fellowship programme will be initiated at the outset,
with due regard to the specific needs that must be met in Spain. In accordance
with its international interest the National Centre of Biotechnology will have
a specific programme of scholarships for graduates from Latin American and
African countries. About 15 such scholarship places are envisaged.
In the early stages it is envisaged that senior staff will be supported by
4 Visiting Professors, 15 graduate technicians and engineers, 20 laboratory
technicians and some 20 young postdoctoral scientists.
EQUIPMENT AND UTILITIES
During the launch phase some 400 million ptas will be required.
P ROJECT F INANCING AND COLLABORATIVE RESEARCH WITH INDUSTRY
The National Biotechnology Centre is expected to participate on a
competitive basis for projects and funds managed by either government or
industry.
Management
The Mobilising Programme is to be managed by a Programme
Committee consisting of scientists and technologists. They will take the
110
responsibility of making proposals according to scientific merit, technological
interest and economic practicability in the following areas:
1. Personnel selection for their training in Spain and in foreign centres
of excellence;
2. Infrastructure endowment (utilities and equipment);
3. Selection and funding of research projects and contracts with
industry after appropriate peer review procedures;
4. Evaluation and follow up of results obtained;
5. Modifications to the Programme in consultation with both academia
and industry;
6. Temporary programming of the aforementioned actions and coordination with related programmes, especially those of the CDTI;
7. Direct promotion of R&D programmes of special interest not
covered by existing recommendations.
Priorities
In accordance with the needs identified by the Programme
Committee, taking into account the scientific and technological competence
available in Spain the following fields will be promoted by the Programme:
General Interest:
Development of systems for genetic manipulation in organisms of
interest for biotechnology;
Development of animal and plant cell cultures related to their
potential applications in biotechnology;
Development of enzymatic and other biochemical processes with
potential biotechnological application.
Bioconversion of lignocellulose materials
Pesticides.
Health Area:
New generation antibiotics;
Immunology: vaccines, diagnostics, antigens, allergens;
Blood proteins;
Peptides, proteins and enzymes.
Industrial Area:
Microbial mining;
Recovery of heavy metals;
Organic acids;
Bioconversion-bioreactors.
Biodegradation and Pollution Control:
Residue and effluent biotransformation;
Microbial ponds for water purification;
Microbial purification of metal contaminated waters
P REDICTED COST OF THE P ROGRAMME
Item
Millions of pesetas Millions of ECU % of total cost
Staff training
1 622
11.2
18
Researchers and contracted personnel
1 380
9.5
15
Infrastructure
2 000
13.8
22
Projects
1 600
11.0
17.5
R&D industrial concertation
2 240
15.5
24.5
Business plan, other expenses
270
1.9
3
Totals
9 112
62.9
100
Note: running costs (salaries, maintenance etc.) of the research system are not included in the
budgeting
Agriculture and Food Area:
Genetic improvement in plant breeding;
Nitrogen fixation;
Improvement of fermentation processes (wines, dairy products,
fermented drinks);
Improved microbial starter cultures;
111
112
foster the development of biotechnology in industry with the objectives
shown in Table 2.
1.11. THE UNITED KINGDOM
Roy Smither
Introduction
During the last half century biotechnology has undergone radical
changes. Historically British scientists and technologists have played a key
role in this development.
Table 1. A few dates in the history of UK biotechnology
1796
Smallpox vaccination, Jenner
1843
World’s first agricultural research station founded at Rothamsted
1923
Isolation of insulin, Macleod e al
1928
Discovery of penicillin, Fleming
1946
Large scale penicillin production, Glaxo
1950
Food preservative antibiotic, nisi, NIRD
1950s
Modified penicillins, Beecham
Cephalosporins, Oxford
1953
DNA structure, Crick, Wilkins and Watson
1957
Interferon, NIMR, London
1958
Insulin structure, Sanger
1961
Foot and mouth disease vaccine, ARC
1967
Marek’s disease vaccine, ARC
1975
Monoclonal antibodies, Milstein
1980
Pruteen, ICI
1980s
Fungal protein for human consumption, RHM
1980s
Cloned oil palm trees, Unilever
1984
Monoclonal antibodies for purification of gamma interferon, Celltech
Government Spearhead
In 1980 the Spinks Report paved the way for accelerated development
in both industrial and academic biotechnology. More than 20
recommendations were made, of which most have been implemented. The
Department of Trade and Industry, DTI, took over the lead responsibility for
biotechnology and in 1982 the Secretary of State launched a campaign to
113
Table 2. Five key objectives of DTI support
– Raise awareness of opportunities for biotechnology – consultancy support
– Raise level of industrial research & development – innovation support
– Improve biotechnology infrastructure – culture collective, information services
– Identify and tackle strategic weaknesses – expensive agricultural raw materials
– Identify and promote sectors of biotechnology that represent particularly
important opportunities for UK
To implement these priorities the Government Chemist established a
Biotechnology Unit, BTU, staffed by civil servants and secondees from
industry. With eight staff the BTU has been effective in ensuring the proper
appraisal of proposals for support from industry. The BTU has also been
pro-active in identifying and promoting biotechnology sectors of industrial
significance, described in more detail later.
Key Objectives
1. Awareness
The Department’s initiative in supporting biotechnology is part of a
wider scheme known as Support for Business’, which also embraces other
key technologies. Various levels of support were available to companies
(ranging from large multinational to the novice, one man start-up) to
employ a consultant to provide specialist skills that the company did not
possess. The BTU had more than 100 candidate consultants which it could
call upon. Discontinued now, largely because of its success, the DTI
provided almost £0.64 million for consultancy support. Waste treatment
proved to be a surprisingly interesting sector. Consultancy support was
followed up to assess the impact achieved. A high level of success was
achieved as judged by further development within a company, according to
the follow-up studies.
Other awareness raising activities include the launch of a pilot
scheme to provide fermenters to secondary schools, support to the Open
University to produce a series of videos, and the publication in 1984 of the
Directory of British Biotechnology. A second edition was produced by a
private company at the end of 1986.
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Microbiological Information Culture Service. MiCIS went ‘on line’ in March
2. Research and Development
Support for innovative research encourages companies to spend more
on high risk projects that would not have proceeded otherwise. This
involves the largest element of spending to date. A grant of up to 25°/0 of
eligible costs is payable to a single company, but no single project has
received support for more than three years. About half the 200 proposals
received have been funded. Company support for the projects outlined is
estimated at around £50 million (April 1987 figures) with DTI support at
£13.179 million. Additional support for collaborative research exceeded
£10.323 million.
Although biotechnology is moving at a fast pace, it is too soon to see
any commercial benefits, although some R&D projects are beginning to bear
fruit. Two examples of the fruits of R&D support are (i) ICI Agricultural
Division – production of polyhydroxybutyrate, PHB, from micro-organisms.
(ii) Amersham International – the development of the Amerlite,
luminescent immunoassay system.
3. Infrastructure
Although the DTI takes the central role in supporting industrial
biotechnology, many other Departments are concerned with aspects of
health, agriculture, environment, energy etc. Co-ordination is maintained by
the Interdepartmental Committee on Biotechnology, ICBT, for which the
BTU supplies the secretariat. This co-ordinating activity has resulted in the
production of a simple guide to UK regulations and regulatory bodies, a
document of particular value for companies new to biotechnology. The BTU
also provides the secretariat to the Industrial Consultative Committee on
Biotechnology, chaired by a DTI Minister and consisting of senior
industrialists. Its terms of reference are to identify and recommend to
government, priorities and policies that encourage the exploitation of
biotechnology by UK industry.
The BTU underpins certain strategic technologies by major funding of
two public sector laboratories, widely regarded as centres of excellence:
Harwell and the Centre for Applied Microbiological Research, Porton.
To facilitate access to data from the UK’s 9 microbial culture
collections, the BTU has instigated the formation of MiCIS, the
115
1987 and enables subscribers to make cost savings on microbial selection. It
is hoped that MiCIS might eventually become part of a pan-European data
bank.
A DTI survey on regulation revealed that the UK regime is regarded as
sensible, pragmatic and generally preferable to other national regimes. It
allows innovation to flourish, while offering adequate safeguards to the
worker and consumer. Patenting has produced problems, particularly with
regard to the basic patentability of biological innovations. Plants cannot be
patented in the UK, although the DTI’s view is that the protection offered
under the Plant Varieties Act is no longer adequate. The ICBT is of the view
that UK law on patents should be harmonised with the European Patent
Convention in restricting access to cultures deposited for patent purposes.
The DTI feels that UK law must change to harmonise it with the situation in
the USA and elsewhere.
With regard to control of genetic manipulation, the DTI is concerned
to avoid the imposition of new controls on industry, except where clearly
justified. In view of the anticipated large increase in type and frequency of
environmental release, it is likely that the existing Advisory Committee for
Genetic Manipulation case-by-case review system may need revision. The
OECD report of 1986 provides a framework for new controls. The DTI has
recommended to the European Commission, EC, that risk assessment should
figure largely in new biotechnology programmes.
The DTI is prepared to co-ordinate UK industrial input into the EC risk
assessment programme and assist in making links with European and other
countries. It is keen to stimulate interest in an awareness campaign about
biotechnology aimed at the general public, to dispel any ill-formed public
perceptions, especially with reference to planned release.
Most organisations active in biotechnology have representation on
appropriate committees. Two bodies stand out at present, the British Coordinating Committee for Biotechnology, BCCB, representing professional
bodies and the Association for the Advancement of British Biotechnology,
AABB, acting for industry and open to companies, non-profit organisations
and individuals.
116
4. Priority Sectors
Because the scope of biotechnology is so broad, the BTU has analysed
the technology on a sectoral basis, taking into account the following aspects:
market characteristics, UK sectoral characteristics, technology development
characteristics, the relevant UK technology base and a suggested strategy for
future development. An action plan gives five sectors a priority status:
Enzymes (biotransformations)
Diagnostics (biosensors)
Agriculture
Food
Process plant/instrumentation
It is believed that these sectors, taking into account UK strengths
and weaknesses, will afford the country major opportunities in future.
Gradually the major biotechnology firms are agreeing with the
notion that collaborative research, particularly at the precompetitive stage,
is a sensible and viable solution to very costly research, especially when
the DTI is prepared to fund up to 50% of programme costs. Successful
ventures include the development of biosensors by Amersham
International, Thorn EMI and the National Institute of Medical Research
and also the development of the novel food, mycoprotein developed in
collaboration by Rank Hovis McDougal and ICI. Examples of the larger
consortia are listed in Table 3, below. The largest of these, the Plant Gene
Tool Kit’ is a £3million/3 year programme involving 11 companies, 2
universities and 2 research institutes, which will develop routine methods
for the transfer of genes into plant material. Each participant has free
access to all research results.
Table 3. DTI Sponsored consortia
Consortium
Objective
rDNA and antibiotics
To improve understanding
and control of antibiotic
production
Institute of
To extend useful life of
immobilised biocatalysts
Biotechnological Studies
in bioreactors
Leicester Biocentre
To improve expression of
foreign proteins in yeast
Plant gene tool kit
To develop gene
manipulation techniques
for crop plants
Enzyme supplementation Make low grade animal
feeds suitable for nonof animal feeds
rumants
Rapid microbiology using Development rapid
detection and enumeration
ATP bioluminescence
systems for bacteria in
industrial situations
Members
4 firms + SERC at 6
universities
7 firms at 3 universities
5 firms at 1 university
11 firms at 2 universities
and 2 institutes
7 firms at 2 research
organisations
5 research organisations
and many firms
Even when 5 or 6 firms collaborate, large research programmes are
expensive. This expense can be reduced if a university or research
organisation is used as the focus for the establishment of a club with a
specific research activity. This situation allows members to tackle problems
of general interest, producing state of the art reports for the benefit of
members. It is expected that membership fees cover at least 50% of the
costs so that viability is ultimately linked to industrial interest. The BIOSEP
club focusing on downstream processing and separation technology
involves over 50 companies, some foreign. The DTI supports a number of
clubs and could consider the support of others.
The organisations that can be supported are listed in Table 4.
Training
The universities and Research Councils undertake most of the basic
research and provide the kernel of trained manpower for industrial
biotechnology. The quality of basic research in the UK is high and arguably
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second only to the USA, with its huge resources. Generally the UK provides
the right blend of talent for its industrial needs, although there may be
shortfalls in specific areas such as immunology. The education system in
the UK is flexible enough to be able to respond rapidly and redress any
adverse trends. Education is thus in a state of dynamic equilibrium,
carefully pivoted to cope with the increasing demands of industry.
Table 4. Who Does the DTI Support?
Single companies directly
Other companies
Consultants
Companies
Research organisations
Educational establishment
Hospitals
Consortia of companies (and other organisations)
Clubs
Centres of Excellence
Certain public bodies
Certain foreign companies wishing to research and manufacture in the UK
{
Clearly to achieve the right blend of academic and industrial talent
requires large resources and a co-ordinated approach from government. To
this end the BTU, along with a strong DTI Regional office network, works
closely with the four relevant Department of Education and Science (DES)
Research Councils. Significant liaison is maintained with the Biotechnology
Directorate of the Science and Engineering Research Council, SERC, set up
in 1981 with separate resources for funding research. The emphasis of the
Directorate’s support is for high quality science and technology in the
university sector, which, while addressing basic problems, will also provide
information from which industry would benefit in the short or long term. Its
priority sectors listed below, Table 5, sensibly complement those of the
BTU. Much of SERC supported research is also through the medium of club
or collaborative activities.
To ensure that the UK does not miss out on some of the exciting work
conducted at the AFRC and MRC research institutes, each research council
has spawned a company, backed by city investment, which has exclusive
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rights to certain areas of work conducted in their respective institutes.
Celltech, which exploits much of the MRC monoclonal antibody
developments is now the world leader in bulk monoclonal production.
Agricultural Genetics Company, AGC, unlike Celltech, does not have its
own laboratories, but acts in a venture capital role to ensure exploitation
with industry of high calibre research in certain AFRC institutes.
Table 5. SERC biotechnology directorate, priority sectors.
Process engineering
Bioconversions
Animal cell biotechnology
Plant cell culture
Whole plant biotechnology
Host-vector systems
Biosensors and bioelectronics
Protein engineering
Public Sector Funding of Biotechnology
Since the definition of biotechnology, as used by different funding bodies
is variable, it is difficult to estimate precisely how funds have been allocated.
Table 6. Government R&D funding of biotechnology in the UK
Source
Commitment £million
Medical Research Council, MRC
27
Agricultural and Food Research Council, AFRC
21
Natural Environmental Research Council, NERC
1
Science and Engineering Research Council,, SERC
3
University Grants Committee, UGC
3*
Ministry of Agriculture, Fisheries and Foods, MAFF
4
Department of Trade and Industry, DTI
6
Other government departments
2
Total
67*
*UGC specifically allocated £3M for new biotechnology projects. A much larger level
of funding benefits general funding of biotechnology as part of university R&D.
The MRC distinguishes between work with a clear intent to produce
something of commercial value and basic research, but classes it all as
biotechnology. In contrast, SERC spending by the Biotechnology Directorate is
included above, but the support to relevant bioscience research is far greater.
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International Collaboration
The DTI is keen to encourage international collaboration in certain areas
of biotechnology. The UK plays an active part in the EC Biotechnology Action
Programme and would like to see this further developed, providing it involves
industrial collaboration. Things should be better in the EC Framework
Programme as there are agreed priority sectors, clear objectives for evaluation
and a relationship between Framework and Eureka. Eureka’s philosophy
involves the exploitation of advanced technologies with a global sales
potential best achieved collaboratively within Europe, where companies lead
in identifying and conducting projects. Biotechnology has had until now a
rather low profile in Eureka for a number of reasons. Within certain sectors
such as pharmaceuticals, the notion of near market collaboration is
countercultural, as the companies have a long tradition of self sufficiency.
However DTI has come dose to stimulating collaboration in vaccine
development. There could well be more potential for Eureka in the diagnostics
area, where technology is changing at a prodigious pace and all European
companies are threatened by US majors. A particularly important, but hidden,
aspect of Eureka, relates to its value as a lever for regulatory change.
There is also scope for bilateral collaboration between companies in
different countries. Examples include Celltech and the Japanese companies,
Sumimoto Corporation and Sankyo, as well as Delta Biotechnology and the
US company Stroh.
I have outlined UK collaborative programmes covering a wide range
of biotechnological interests. The UK would be willing to internationalise
these if other countries would make equal contributions. The areas
identified as contenders for international involvement include protein
engineering, the genetic manipulation of plants as well as the industrial use
of agricultural surpluses. Equally we would be happy to consider other
countries’ suggestions and help to identify possible industrial participants
for such collaboration, especially under Eureka.
Inward Investment
Many overseas companies are becoming interested in the UK as a
centre for investment and R&D in biotechnology, not least because of its
record of a commonsense approach to product regulation, and effective and
predictable approval processes. US biotechnology companies have already
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invested in manufacturing facilities for healthcare, biochemicals, biosensors
and micropropagation. They have been attracted by the same combination
of excellent manufacturing sites, strength in life science R&D, and high
quality clinical trials that have made the UK the predominant European
country for US pharmaceutical investment for many years. Examples are
Welcome and Schering Plough who both recently obtained UK Government
approval for the sale of α-interferon, a major event in the development of
therapeutics through biotechnology.
The BTU works closely with the Invest in Britain Bureau to attract
further investment. Seminars have been held in the USA, Japan and other Far
Eastern countries to persuade companies in those countries that the UK is the
natural focus for investment to meet the needs of the European market.
Conclusion
It is the belief in the UK that the prime motivator of biotechnology is
industry, although this is complemented by a fair fiscal and regulatory
regime. The country has a lively and successful biotechnology industry, with
tariff free access to the European Market of over 400 million people. It is a
centre for growth in which products can be developed and marketed quickly.
It has a strong academic base and a large pool of highly trained manpower.
With its regional investment grants and its highly developed private financial
sector, the UK is one of the preferred locations for biotechnology.
There are numerous opportunities for improved international
collaboration and the UK is ready to do its part in seeking parties for
projects appropriate for collaborative research.
Postscript
Since January 1988 a change in DTI policy has transformed the
focus of industrial support for technology, including biotechnology.
The emphasis is away from providing support to individual
companies and now concentrates on exploitation of technology through
collaboration. There are several ways in which the DTI, with other
government Departments in some cases, will encourage and finance
collaborative research:
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encourages companies to undertake joint, pre-competitive but
industrially relevant research with the academic base. Biotechnology
programmes have been agreed in eukaryotic genetic engineering
(£4.7M/4 years), biotransformations (£4.0M/4 years), selective drug
delivery and targeting (£3.0M/5 years) and food processing sciences
(£14.0M/5 years), whilst a further programme of protein engineering
is in the pipeline.
LINK
SECTION TWO
BIOTECHNOLOGY IN LATIN AMERICA
National collaborative/ general industrial reasearch programmes
encourage collaboration between companies in precompetitive
research outside the specific focus of LINK, and may or may not
involve academics.
EUREKA encourages industrially led projects with EC or other
European partners. These should both strengthen European
technological capability in world markets and contribute to the
completion of the Single European Market (1992)
Up to 50% government funding is available for all of these schemes.
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COMMENTS
Luis Ramiro Alfonsin
By His Excellency Mr., Ambassador of Argentina to the EEC
It is an honour for me to be able to participate in this Seminar on
Biotechnology in Europe and Latin America’ in the company of a group of
scientists, industrialists and government officials.
Some aspects of biotechnology are presented as one of the most
stimulating sciences of our time.
In Latin America, one has managed to successfully manipulate some
of the most traditional aspects of biotechnology, such as the improvement
of plant and animal species.
Our progress is not as obvious in other sectors of more recent
discoveries such as new genetic engineering techniques.
Some scientists agree that progress in biotechnology will have a
negative effect on developing countries. Others think that it will be
difficult for poor countries to benefit from numerous advances which take
place in this sector.
I personally think that no futurologist feels at his ease when his
forecasts do not come true. But whatever the final result, Latin America
will not be able to remain outside the development of biotechnology. This is
why I enthusiastically congratulate the organisers of this seminar for their
idea to gather men and women of both continents showing an interest in
these themes.
Many of the businesses created to use genetic engineering for the
discovery of new processes or products have resulted from the vision and
enthusiasm of the scientists who have imagined the potential results from
these recently introduced tools. It seems that it was not very difficult for
these pioneers to communicate their enthusiasm to investors willing to take
the risk and to accompany them in their dreams. This was followed by
hardship, frustrations, and elusive results for which one has had to make an
effort in order not to be despondent. This is how this young industry has
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had to mature in a very short time and without giving way to despair, has
had to learn to be satisfied with more realistic objectives or be more patient,
but always keeping in mind the possibility of making surprising discoveries.
One sees today an industry which is starting to move steadily, even if
this sector is not suitable for people without courage or for those who do
not want to take risks.
I imagine that from the point of view of the scientist, the researcher,
the present climate of biotechnology is something like an ideal
environment. It appears as an enormous sector presenting great possibilities
which researchers, as well as entrepreneurs and scientific research policy
makers, should distance before deciding where to direct the efforts and the
resources, which are always limited.
It is certain that Europe will attempt to dedicate itself to highly
sophisticated small scale productions wherein costs and ingredients coming
from plants or animals have a relatively small importance.
I think that there are three different sectors in which biotechnology
can bring fundamental advances for humanity.
Undoubtedly what is most important is the pharmaceutical sector
which appears to present an almost unlimited range of possibilities both for
medicines as well as for diagnoses. Possible progress in the pharmaceutical
sector is the one most stimulating our imagination and our hope. Results
which were hardly envisageable have been obtained this century. This
brings to mind insulin, tissue plasminogen activator, vaccines against
malaria or Chagas’ disease which preoccupies us so much, or more efficient
vaccines against foot and mouth disease and of course, the whole area of
immunology and fight against cancer.
A different fundamental sector for biotechnology is the production of
basic chemical products from material of organic origin. One should start to
be ready for the time of scarcity of reserves of raw materials. For several
decades, Argentina has produced acetone, butane and ethane from cereals
and sugar through fermentation. Brazil produces large quantities of ethane
through fermentation of sugar. Microbial processes could help to solve
problems relating to environmental contamination and at the same time
produce fuel and chemical products. In contradiction to these advances, it is
surprising to see large projects proposed that are based on European
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agricultural production which is produced at terribly high cost and which
requires enormous subsidies in order to be able to be used for these
industries. It seems to me more reasonable to install these industries in
countries with a more efficient system of agriculture where the investors
will not depend on political change, protectionism or to subsidies.
The other interesting sector for biotechnology is agricultural
production. Possibilities for improvement are also nearly infinite and the
needs of humanity are very urgent in this sector. However, Europe also
needs to correct immediately the expensive inefficiency of its agriculture. It
would be wrong to continue to produce at exceedingly high costs whilst
sheltering itself inside a protectionism which causes prejudices. Europe
needs to start looking for new varieties of cultures which do not require as
many fertilisers or pesticides to be ready when the time comes to honestly
compete at a world level. The research in new symbiotic systems has to be
intensified which will enable the exploitation of atmospheric nitro-gens for
surface plants reducing costs and water contamination. It is very interesting
to discover new varieties adaptable to zones of little rainfall or finding
methods of cultivation which reduce water requirements. The utilisation of
bacteria in the fight against the effect of frost seems very promising and it
should be possible to introduce new cultures to areas having short summers.
Europe could profit from annual cultures producing cellulose at acceptable
costs. It is also interesting to find saline resistant cultures.
countries in the biotechnological sector, as well as in other scientific and
industrial sectors, especially if we take into consideration the fact that the
development of some products, without economic interest for the developed
countries, may be of vital importance for us.
Europe and Latin America can collaborate and be complementary in
this exciting adventure of biotechnology. I think that there will be advances
in research, development and production which could be realised at a lower
cost in Latin America than in Europe.
This first meeting will help to make experts from both continents
familiar with each other. I expect that this meeting will be successful.
Interesting ideas for all participants will be brought forward. I hope that at the
end of the meeting they will already be thinking of the next seminar. Along
these fines, I allow myself to urge the organisers, enriched by the experience
gained during this meeting, to continue with the idea of maintaining this kind of
contact which will certainly be of great interest to both regions.
The European consumer will want many agricultural products to
regain the flavour and the quality they had in the past and which were lost
because of technical methods that can be only used in the community
market which allows high prices independent of quality.
With so much work to be achieved, it does not seem reasonable to
devote efforts and scarce funds to try to increase production by high cost
technical methods which make it impossible to resist honest competition.
The Latin American technicians want to collaborate in this scientific
research. Latin American agriculturists are not afraid to compete on an
equal footing with European agriculturists. It is not possible to compete
with funds from the North American Treasury or Community budgets.
This does not mean that Latin America must give up participating in
the development of sophisticated techniques. On the contrary, we feel
obliged to reduce the gap which separates us from the industrialised
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been aggravated by a hostile reaction to Latin America’s generally ‘Laissez
Faire’ approach to intellectual property protection.
2.0. OVERVIEW OF LATIN AMERICAN
ACTIVITIES IN BIOTECHNOLOGY
Karl Simpson
It has been too easy for Europeans to dismiss Latin America as being
a collection of underprivileged third world states. It is true that debt
continues to be a pressing problem for almost all of Latin America’s
economies, but in 1988 Brazil and Mexico seem to be regaining the
confidence of the world’s financial centres. Argentina’s recent re-entry into
democracy is a further cause for optimism and in Chile (ignored in
SOBELA) there is growing hope of a democratic conclusion to Pinochet’s
regime.
Each of the Latin American states, but most notably, Argentina,
Brazil, Mexico and Venezuela, has a substantial business class, enjoying
access to European standards of education, health and consumer
commodities. Industrial output, while largely low-tech, has increasingly
focused upon new technologies emerging from the R&D based cultures of
the USA, Japan and Europe.
In several areas of biotechnology a number of Latin American
nationals have made substantial contributions. Cesar Milstein (Argentinean
citizen) gained his Nobel Prize for work on hybridomas. It cannot be
overlooked that in the event of substantial improvement in living and
working conditions, Latin America may be able to call upon the skills of
many technically qualified expatriates working in centres of excellence
throughout the world. Both Argentina and Brazil have traditions of
excellence in basic research and have a number of long established and
internationally recognised laboratories.
In 1984 the United States Office of Technology Assessment, OTA,
suggested that the Latin American market for biotechnology would be
exploited by the USA and Japan. Europe, they reasoned would not be able to
establish a presence. By 1988 it has become clear that Europe has moved
and is now establishing a strong position in Latin America, although
Japan’s involvement is very strong. Paradoxically it is the USA that has
failed to capitalise upon its proximity to Latin American markets. This has
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A growing sense of community is emerging in Latin America and
this is manifest by an increasing number of joint activities in areas of
strategic interest such as biotechnology. The states of the Andean Pact have
effectively devolved national responsibility to the supra national
responsibility of the Pact. Professional Associations such as Brazil’s
ABRABI (Associação Brasileira de Empresas de Biotecnologias) are
spreading throughout the region.
A sense of realism prevails in most of the states. It is realised that
commitment to biotechnology is not immediately going to force a dominant
position in world markets. It seems more likely that the short term
advantages of developments will be a reduction in foreign imports, such as
AIDS diagnostic kits or insulin. In the long term it is possible that relatively
cheap labour costs and a well educated professional class might permit the
exploitation of world markets on an equal footing with companies in
Europe, the USA and Japan.
One of the consequences of SOBELA may well be the establishment of
joint ventures that realise these hopes in the short term.
In the following lines we paint a very brief picture of biotechnology
in the states presented at the SOBELA meeting.
Argentina
The election of a civil government in 1984 gave impetus to the
National Biotechnology Programme, PNB, launched in 1982. Nobel
Laureate, Dr Luis Federico Leloir, heads the Executive Committee of the
PNB. With major support from the National Department of Science and
Technology and the National Council for Scientific and Technical
Research, as well as significant input from other ministries, the PNB is
orientated towards servicing the needs of industry. Human health and
livestock health and improvement have been defined as priorities for the
PNB. In the period 1984-86 US$1.6 million was divided between 90 projects
in 70 centres. From a European point of view such expenditure would seem
to be spread very thinly.
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Training is a key issue in the Programme and grants are made
available for scientists to train in foreign countries. The EEC has been
asked for financial support in this area. The PNB is orientated towards
international collaboration and links with several countries in Europe exist
already (Belgium, France, Federal Republic of Germany, Italy and
Sweden). Internal cooperation and particularly the cementation of strong
industry/university links are essential if the Programme is to meet its
goals. Individual entrepreneurs are expected to take the initiative in
establishing such finks, while the PNB will support the activities of a
representative body, the Argentine Forum of Biotechnology. Launched in
1986 its President, Dr Aldo Ferrer is also President of the Bank of the
Province of Buenos Aires.
A fiscal package has been agreed which accords credit certificates to
a value of 60% of the cost of approved projects. This is also available to
foreign entrepreneurs investing in Argentina.
Argentina has developed particularly dose links with Brazil,
manifest in the foundation of a joint centre for biotechnology. On this
background of activities there is an increase in interest and investment in
industrial biotechnology.
Brazil
With an academic tradition in the biological sciences dating back to
the mid 19th century Brazil has a commanding lead over its neighbours. São
Paulo, active from the beginning has become the focus for institutes
operating in the areas of vaccines, immunology etc. Successful public
health campaigns are making progress in the control of typhus,
leishmaniasis and other diseases. Agrobiotechnology has achieved some
notable successes, using very traditional technologies. Brazil has
established commercially valuable Maize hybrids.
There is a strong commercial base for exploiting innovation in
biotechnology. Agroceres, the seeds company, was founded in the 1940s.
In the 1960s Brasilsul and Agropecuária were founded. These companies
can trace their evolution to the work of plant geneticist, Cruz Martins in
the 1920s. Other distinguished Brazilian geneticists include Dr
Theodosious Dobzhansky.
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Companies with an interest in biotechnology have guaranteed Brazil
self sufficiency in insulin production, and are looking closely at the local
manufacture of products including the interferons. Arable and stock
farming is served by many universities and institutes, several of which now
boast competence in gene manipulation. Selection of soya cultivars has
resulted in an 80% increase in nitrogen use efficiency in the last 20 years.
Genargen has established germ plasm banks, which will help offer
protection from North American, Japanese and European companies hoping
to exploit Brazil’s vast phytochemical resources.
Biotechnology in Brazil cannot ignore the Proalcohol Programme,
although this is coming under increasing internal criticism. The programme
did much to stimulate local biotechnology related industry and incited
contacts with companies such as Denmark’s Novo, who became interested
in the prospects of selling starch converting enzymes. Perhaps the long-term
benefit of the programme will have been the accumulation of know-how in
all aspects of the sugar complex.
Although the Ministry of Science and Technology accepts
responsibility for control and co-ordination of Brazilian biotechnology, the
government, as in Argentina, looks to entrepreneurs to provide the
industrial impetus to the programme. More so than anywhere in Latin
America industrialists have come forward to launch companies in areas
ranging from micropropagation of plants to AIDS diagnostics.
Examples of companies include: Biobras, interested in the
manufacture of genetically engineered insulin. Bio-Planta in association
with Native Plants have set up an agrobiotechnology research centre.
Cibran, the antibiotics company is implementing rDNA technology in its
R&D facility. Embrapa is a public sector company which has a commitment
to the exploitation of Brazil’s germ plasm resources.
In the public sector the Oswald Cruz Foundation and the Butantã
Institute make a major contribution towards biotechnology R&D. Many of
the new companies will participate in the formation of regional poles of
biotechnology, where private/public sector integration will be a feature.
This activity mirrors what is going on in France.
In Brazil there is a growing concern that biotechnology may threaten
the future of employment in the agricultural industry. Increased
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productivity may seriously damage the organisation of society in areas
removed from major cities.
Mexico
Although Mexico has a number of university departments with
competence in several aspects of biological science it is true to say that
industrial exploitation of biotechnology is dominated by first generation
technology. Such technology is manifest in the production of beers and
spirits. Second generation technology is used for the production of
antibiotics, amino acids and aspartame sweeteners, but all of this
technology has been imported from foreign countries.
Several small scale industrial enterprises have been launched to
capitalise upon the market for the products of this technology. Enzymology,
based in Monterrey, is a company manufacturing aspartame, phenylacetic
acid and related chemicals. Bioenzimas, in Saltillo, Coahuila, is an agrobiotechnology company with interests in improved grain yields,
insecticides, giberellic acid and agricultural enzymes.
Modern biotechnological innovations such as micropropagation are
being initiated by a small number of firms including: Industrial biogenetics,
involved in the micropropagation of strawberries, asparagus and violets;
Genin, who are working on immobilised enzyme bioreactors and the
Forestal Center of Genetics, dedicated to genetic improvement of forests by
micropropagation.
Gene manipulation and hybridoma technology are found only in
government funded laboratories and universities. In these centres
biochemistry and related sciences have been established since the 1930s.
Biochemical engineering degrees are awarded by more than 20 institutions,
with 7 centres offering postgraduate training.
The Andean Pact
Bolivia, Columbia, Ecuador, Peru and Venezuela
The Andean Pact is a structure similar to the EEC. Most of the
member states do not have the resources required to fund major
programmes in high technology. Under the auspices of the Pact central
facilities and concertation measures optimise those skills and technologies
133
available. An Andean Biotechnology Programme has existed since 1986.
Within the members of the pact there is considerable variation in wealth
and scientific competence. The Andean Council for Science and
Technology has principal responsibility for concertation of biotechnology
actions within the Andean Pact.
Bolivia is not advanced, but does have a programme focusing on
Embryo transfer between species of South American Camelidae. Work is
carried out in the Instituto de Genetica Humana, where a programme on the
molecular biology of diarrhoea is also active. In 1985 Peru and Bolivia
launched the Andean Mining/Metallurgical Programme, PMMA. One aspect
of this titled, biohydrometallurgy, concentrates upon the extraction of
metals by microbial leaching.
Columbia has a very ambitious National Biotechnology Programme,
but given the present level of trained personnel and appropriate facilities it is
difficult to see how the programme can be implemented in its present form.
Ecuador has indulged in some limited biotechnological work since
1983, but a realistic government cannot contemplate a significant National
Programme. Training is singled out as the most important requirement in
the National Plan for biotechnology. Government laboratories are carrying
out R&D in aquaculture, in collaboration with commercial interests. Inexa
SA is a small company carrying out meristem culture in collaboration with
university laboratories. Pronatec SA is studying the commercial exploitation
of natural extracts. Life SA in collaboration with the Instituto Nacional de
Higiene is manufacturing vaccines for animals. Levapan is developing
fermentation technology. There is hope that it may be possible to stimulate
the pharmaceuticals industry by applying rDNA technology and other
aspects of modern biotechnology.
Peru has little infrastructure capable of supporting advanced applications
of biotechnology. It is the mining industry which has turned to bacterial
leaching as a possible tool for the extraction of metal from unworkable
deposits. The government sector has some activities in plant biotechnology. A
joint programme with Bolivia, supported by the Federal Republic of Germany
expands upon national competence in microbial leaching.
Until recently Venezuela has had the privilege of having the highest
per capita earnings in Latin America. Decline in oil revenues is forcing a re134
evaluation of national goals. Biotechnology is seen as a tool with
considerable potential and a programme launched in 1984 concentrates on
three major areas: Agriculture, Medicine and Industry. In Agriculture the
focus of effort is upon the production of pathogen free plants through
somatic hybridisation and tissue culture. The potato and yucca plants are
the targets for exploitation. Medical priorities include assault upon regional
diseases and the development of competence in monoclonal and polyclonal
antibody production to back up a domestic competence in diagnostics
targeted at cancer, AIDS and epidemiology. rDNA technology is on the
agenda for developing gene probes and therapeutic agents.
2.1. ARGENTINA
José La Torre
Sara B. de Rietti
Structure and Operation of the National Biotechnology Programme
The National Programme of Technology (PNB) was created at the end
of 1982, even if it only became popular in 1984 with the inauguration of the
constitutional government of Doctor Raul R. Alfonsin. The information
supplied by this Programme is rich in experience but corresponds to a
starting phase. Argentina has a long tradition in biosciences (with three
Nobel Prizes) as well as an important pharmaceutical and biochemical
industry. In 1984, during the initial phase, there were already numerous high
quality research centres in areas linked to the development of
biotechnology. Even if the National Programme of Argentinean
biotechnology is new, its foundations are solid. The Programme has been
organised as an advisory, co-ordinating and financing unity with minimal
administration and wide ranging executive powers. The head of the
National Department of Science and Technology (SECYT) is directly
responsible for the PNB and its management is co-ordinated through the
Secretary of Sciences and Technology. The programme has an Executive
Committee of four members and an Advisory Committee of twenty
members headed by the Honorary President, Dr Luis Federico Leloir, Nobel
Prize for Chemistry.
The Advisory Committee represents public and private research
centres and State and University Institutes as well as the body linking the
industrialists of the biotechnological sector. All the members of the
Executive Committee, and nearly all of the members of the Advisory
Committee, are specialists in disciplines finked to biotechnology from the
various regions of the country. The actual composition of the PNB appears
in Appendix A of this report.
R&D
R&D
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Financing in Biotechnology
One of the basic functions of the PNB is the granting of subsidies for
related to biotechnology. The word basic is used because R&D
136
administrators know that it is a very powerful instrument in the implementation
and shaping of policies. The funds are provided from subsidies budgeted by the
SECYT and by support from the National Council for Scientific and Technical
Research (CONICET) operating in co-ordination with the Programme.
This specific financing is an addition to that granted by other
organisations and sectors of the SECYT with similar aims. One can thus
mention the support of the CONICET for selective basic and applied research
which at least doubles the value of the PNB grants, and the role of the
National Institute of Farming Technology (INTA) which has considerable
resources and programmes. Other support is offered by National
Programmes of the SECYT related to biotechnological aspects of Food
Technologies and Non-Conventional Energies, and subsidies granted by the
SECYT through ‘Apoyo Institucional’, in the same way as the PNB.
The financial support of the PNB is mainly directed to the centres and
laboratories of the public sector. In all its other activities, such as the
interaction between science and production or international co-operation,
those depending on private companies and institutions are also included. In
this way the PNB is a common point for public and private initiatives whose
realisations very often result from a disinterested collaboration of
researchers and private industrialists. Subsidies are granted as a function of
standards and priorities established for each programme.
Interested parties have to present a Pre-Project for which approval is
indispensable to allow detailed examination of the Project. It is advisable to
co-ordinate Pre-Projects with similar topics into an Integrated Research
Programme. Financial support is organised as far as possible for a
maximum period of three years subject to a control of academic and
budgetary administration, which is made by the PNB.
The priorities established by the Programme for the distribution of
subsidies are based both on the research topics and their connection with
the general development of the sector and with the level of technical
innovation reached including the socio-economic impact of the Project. For
the productive importance of research it is essential that the results are
applied in the most direct way to the production of goods or services.
One of the basic objectives of the Programme is to place the
scientific work at the service of the productive activities. This is especially
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so as Argentina, in its present state of development, cannot afford the
luxury of maintaining expensive, non-productive, basic research in a sector
such as biotechnology, which historically presents for the country an
interesting academic development, and that at the same time offers an
enormous productive potential at an international level.
As far as the research topics are concerned, their priority has been
established after many long debates and preference has been given to those
concerning human health and agricultural livestock production. Productive
applications rather than specific research topics have been considered as a
determining condition for the approval of a project but this does not exclude
a proposal favouring the development of any weakness of the sector.
In particular, priority topics of research are the following: 1)
Development of biotechnological processes with special emphasis in the ones
which concern the application of advanced biochemical engineering; 2)
Biological fixation of nitrogen; 3) Plant biotechnology with special emphasis in
molecular biology of plants and cultures of plant tissues; 4) Production of
vaccines and biopharmaceutical products; 5) Diagnostic reagents.
Between December 1984 and December 1986, the PNB approved
subsidies for a value equivalent to more than US$1.6 million distributed
between more than 90 research projects and various plans for equipment at
more than 70 centres and research laboratories throughout the country of
which a substantial number are related to biotechnology.
Vocational Training
Argentina has a rich tradition of professional education in biosciences and has trained high level researchers who work on very advanced
topics in several parts of the world. However, in order to cope with this
challenge of providing a scientific and technical infrastructure capable of
supporting the development of production methods incorporating
biotechnological advances, an effort is required in training and re-education
which implies a qualitative and quantitative change. The PNB is aware of
this situation and in co-ordination with the CONICET has developed an
intensive plan of external grants which will be valid from 1987 onwards.
The support of the European Community will be sought for the
development of this plan and the process of promoting an intense horizontal
co-operation with Latin-American countries has begun.
138
The PNB has given its support to this for the last three years by the
promotion and financing of various activities directed towards the training
and re-education of the researchers such as: intensive theoretical courses,
seminars and conferences organised by research centres, university and
private institutions which has been able to work with foreign or
Argentinean specialists living abroad. International co-operation and a
growing emphasis on the activities of CONICET has channelled support
towards this goal. The purpose of the programme is to intensify activities
finked to training in biotechnology in which international co-operation
plays an important role. All methods such as doctorate or postgraduate
grants and specialists missions are utilised to gain foreign or external
support. In the particular case of Argentina the training must reach all levels
of university lecturers as well as all aspects of administration because of the
scarcity of specialists capable of dealing with scientific projects of the
complexity or the extent required for new technologies.
International Co-operation in Biotechnology
From its inception, the PNB has given preferential attention to
everything which is connected to international co-operation in
biotechnology. With the objective of using offers of co-operation from
countries of higher scientific technological development, Programmes have
allowed the realisation of meetings and scientific seminars which officials,
researchers and foreign entrepreneurs have attended. In particular, the
French-Argentinean meeting in Buenos Aires in 1986 has brought about an
important exchange of ideas and created contacts between the
biotechnological enterprises of both countries. The 1986 cooperation
agreement with Sweden has included five biotechnological projects which
have been completed by Argentinean and Swedish Institutes implying an
important economic and technical contribution. In 1984 an agreement was
made between the Argentinean Republic and the Kingdom of Belgium
which foresees the realisation of twelve joint projects including one on
wheat covering aspects linked to biotechnology. Additionally, Italy and the
Federal Republic of Germany have expressed intentions for co-operation
which are expected to be realised before the end of 1987. To promote
regional co-operation, taking into account the integral complementary
economic policy of the Argentinean Government, the PNB has allowed joint
139
meetings of officials, researchers and entrepreneurs linked to biotechnology
with other Latin-American countries, especially Brazil.
It has actively taken part in setting up the Regional Programme in
biotechnology for Latin-America and the Caribbean patronized by the
PNUD, UNESCO and UNIDO and has a large responsibility for
commercialisation, which is of great importance for the development of
biotechnology. The first director of the Argentinean-Brazilian Centre in
Biotechnology (CABBIO) serving a three-year term is a member of the
Executive Committee of the PNB.
Models for Internal Co-operation
The PNB has started a number of interdisciplinary co-operative
activities inside Argentina to realise policy.
The fundamental objective of the Programme is to obtain as close a
contact as possible between the productive sector and the research centre as
well as the various State run or supported laboratories. This inter-relation is
established through active participation of representatives of private
enterprises and activities promoted by the Programme, either in national or
international meetings or in a Commission or Working Group. The
Programme also stimulates the activities of the committees of scientific and
industrial co-operation which are encouraged by the CONICET. These
committees specify agreements, tasks and results of the R&D Centre and the
nature and amount of payments made by the company consisting of fixed
yearly amounts or sales commissions for a fixed period.
Finally, in order to enlarge the market or to incorporate advanced
technology which allows the support of large industries the PNB organises
meetings between Argentinean and foreign industrialists such as those
bilateral meetings between France and Brazil. An example, involving
France at the end of 1986, was the mission linked to the biotechnological
sector of the EUREKA plan, during which co-operation between Argentinean
and French companies was established.
The link between universities and enterprises is established through
agreements created by CONICET when there are R&D centres or university
laboratories capable of completing such co-operation. In general, the
national universities, particularly the best ones, have experienced a serious
140
recession because of the political vicissitudes during the decades prior to
the present Constitutional Government which provoked a reduction of the
teaching and more qualified scientific staff whose real contribution to the
development of biotechnology helps consolidate a recuperation process
with which the SECYT is deeply involved.
As for the proposed entrepreneurial models, the PNB prefers the
actual entrepreneurs to take the initiatives required in each case. On the
contrary it has been concerned with the creation of a representative body
where both private associations and enterprises as well as public sector
centres linked to biotechnology have a say. This is how the Argentinean
Forum of Biotechnology was created in October 1986 whose president is
also president of one of the main state banks of Argentina and is presently
part of the Consulting Committee of the PNB. The SECYT has created a law
promoting development and technological innovation in production. The
PNB has taken part in these discussions which were presented to the
Congress of the Nation in 1986 and which establish the basis of an
institutional rule in this field. Three possible modalities for the execution of
entrepreneurial technological R&D projects have been established: 1) total
execution of the project by a national centre of R&D contracted by the
company; 2) execution of the project by the company and a national R&D
centre in which each of the parties must realise distinct and complementary
tasks and 3) total execution of the project by the company under fixed
conditions determined by the law and subject to a technical and accounting
verification by the SECYT. The concept of the national R&D centre covers
laboratories, professor-ships and state institutions (such as the INTA) and
others allowed by the SECYT.
The benefit for the company consists of the delivery of fiscal credit
certificates for the payment of national tax equivalent to 60% of the cost of
the approved project. This type of benefit is also available to companies of
foreign capital established in Argentina and the approval for these projects
is given by the SECYT. This is subject to priority criteria fixed by law which
takes into consideration the contribution to the national economy and to the
promotion of exports.
141
Scientific and Technological Co-operation between Europe and Argentina
As already mentioned, Argentina has realised co-operation
agreements linked to biotechnology with Belgium, France and Sweden and
is in a very advanced preparation stage of programmes for which it shows a
great interest, with Italy, and the Federal Republic of Germany.
To reinforce the existing co-operation and the permanent how of
information the following is suggested:
a) The initiation of intensive training, education and coaching of the
R&D staff at all levels including the administration of projects
within the framework of the plans drawn up by the PNB.
b) The completion of joint R&D projects in biotechnology on topics
considered as priority ones by the PNB with the exchange of
specialists and contribution to the technological equipment needed
by Argentina.
c) The establishment of industrial plants which bring advanced
technologies and employ local personnel at all levels. They are
obliged to dedicate a substantial percentage of profits to R&D for
which local professionals trained by investors are responsible and a
substantial percentage of production to export.
d) Association of European companies with Argentinean companies in
which the effective transfer of technologies brought by the
European side is certain.
e) Establishment of international services of scientific and
technological data bases related to biotechnology which are
accessible to public and private entities in Argentina.
f) Creation of information and documentation committees in
European cultural diffusion agencies operating in Argentina.
In particular, support is needed to set up a R&D centre for industrial
farming production in the rich damp pampa of Argentina equipped with a
system of enormous productive potentiality. The scientific and
technological training tasks of the new centre will be closely linked to the
production activities of the area characterised by the very interesting
142
problems of dealing with the natural environment, plant and animal health
and productivity.
APPENDIX A: DEPARTMENT OF SCIENCE AND T ECHNOLOGY
N ATIONAL B IOTECHNOLOGY P ROGRAMME
Secretary of Science and Technology
Dr Manuel SADOSKY
Co-ordination of the programme
Dra Sara BARTFELD de RIETTI
Executive Committee
Eng Agr Guillermo JOANDET, National Director Assistant and Researcher
Consultant of the INTA.
Dr Alberto KORNBLIHTT, Assistant Professor, sector of Molecular Genetics,
of the Faculty of Exact and Natural Sciences of the University of
Buenos Aires.
Eng Agr Carlos LOPEX SAUBIDET, President of the INTA.
Eng Hugo MACCIONI, Independent Researcher of the CONICET. Titulary
Teacher, Chair of Biology, Faculty of Medicine, U.N. of Cordoba.
Eng Enrique MARTINEZ, President of the INTI.
Dr Oscar BURRONE
Dr Jose LA TORRE
Dr Alberto MARCIPAR
Dr Faustino SINERIZ
Consulting Committee
Dr Luis Federico LELOIR, Honorary President.
Dr Carlos R. ABELEDO, President of the CONICET.
Dr Israel ALGRANATI, Head Researcher of the CONICET, Institute of
biochemical research ‘Foundation Campomar’, Buenos Aires.
Dr Diego DE MENDOZA, Director of the Department of Microbiology of the
Faculty of Biological and Pharmaceutical Sciences of the U.N. of
Rosario.
Dr Alberto DIAZ, Director of Biosidus SA.
Eng Agr Luis MROGINSKI, Independent Researcher of the CONICET.
Institute of Botanics of the North East, Corrientes.
Dra Elsa SEGURA, Director of the Institute of Research of the Department of
Public Health. Director of the Institute of Research for Chagas’illness
‘Dr Mario Fatala Chaben’.
Dr Hector TORRES, Director of the Institute of Research in Genetic
Engineering and Molecular Biology and Dean of the Faculty of Exact
and Natural Sciences of the University of Buenos Aires.
Dr Raul E. TRUCCO, Director of the PROTEP Programme (CONICET-CITEP),
Mar del Plata.
Dr Ruben H. VALLEJOS, Director of the Centre of Photosynthetic and
Biochemical Studies, Rosario.
Dr Rodolfo J. ERTOLA, Director of the Centre of Research in Industrial
Fermentations, La Plata.
Dr Aldo FERRER, President of the Bank of the Province of Buenos Aires
and of the Argentinean Forum of Biotechnology.
Dr Juan GOTTIFREDI, Rector of the U.N. de Salta and Secretary of Sciences
and Technology of the National Interuniversity Committee.
Dr Oscar GRAU, Co-ordinator or the Latin-American Network of
Biotechnology.
Eng Horacio IRAZOQUI, Director of the Institute of Technological
Development for the Chemical Industry, Santa Fe.
143
144
2.2. BRAZIL
Antonio Paes de Carvalho
Again in the field of health, Brazil is carrying out initiatives in
diagnosis methods and biopharmaceuticals of high molecular weight; it is
self-sufficient in insulin and is carrying out research into the production of
interferon and also has the technology to produce blood derivatives,
including human albumin and anti-haemophilic factors.
Background to Brazil’s Biotechnology Policy
Brazilian biotechnology began in the middle of the last century when
pioneer work was carried out in São Paulo on various specialized fields of
microbiology, notably bacteriology, mycology, protozoology, phytopathology
and virology. As a result of the work of these pioneer groups the first institutes
devoted to research on bacteriology, vaccines, and clinical, pharmacological
and immunological analyses sprang up in São Paulo.
Brazil benefited greatly from the results of these early initiatives
which paved the way for successful public health campaigns against
epidemics of yellow fever, trypanosomiasis, leishmaniasis, bubonic plague
and typhus. Important institutes such as Oswaldo Cruz, Adolfo Lutz,
Butantã and Pasteur were also set up, and these are now fully competent to
maintain national progress in the field of biotechnologies applied to health.
In agriculture the technical progress made in the early days of
biotechnology studies applied to seed production made Brazil the second
country in the world, after the United States, to obtain uniform and highyield hybrid maize from fines developed from local genetic stock.
As a result of this process of development and consolidation of
various branches of traditional biotechnology, in particular those related
to agriculture, the first private enterprises in the seed production markets
such as Agroceres sprang up in the forties followed, in the sixties, by
Brasilsul Agropecuária.
As regards the development of genetics, the basis of modern
biotechnology, Brazil’s historical development has its roots in the work of
Cruz Martins, in 1924, together with the Instituto Agronômico de Campinas.
The development of Brazilian genetics is also connected with international
names such as Dr Dreyfus, Dr Krüg, Dr Brieger and Dr Dobzhansky who
were the pillars of Brazilian genetics and left behind many disciples who
became top-level researchers.
145
Arable and Stockfarming
This represents a great development potential for the country since we
now have a number of excellent research institutes and universities covering
various areas such as genetic engineering, cell and tissue culture (USP, IAC,
UNICAMP, EMBRAPA, IAA, UFRJ, UFVIÇOSA, ESAL, IAPAR), and biological
fixing of nitrogen and mycorrhiza (inoculants) (UAPNPBSOLO/ EMBRAPA,
UFRGS, CENA, IPT, IAC, UFV and others).
The most impressive example of nitrogen fixing is the result obtained
by the constant research carried out over the past twenty years with soya
cultivars which, today, can extract 80% more than their nitrogen needs by
biological fixing.
Noteworthy Brazilian technological developments in the field of
plant health, owing to their importance and possible uses, are techniques for
disease detection, pest control, resistance to herbicides and resistance to
diseases and weeds, from endogenous technological development. As
regards pest control in particular, it should be stressed that Brazil is one of
the first countries in the world to undertake a large-scale project to spray
nearly 600.000 hectares with bacullovirus.
Mention should also be made of the experience of Cenargen whose
work has proved to be of growing importance for the systematic
identification and establishment of active germplasm banks.
Bioconversion and Energy
The example of Proalcool, among others, is a clear demonstration of
Brazilian potential for making use of its bioclimatic conditions, coupled
with its technological development, to resolve, using native resources, the
serious question of alternatives to oil. In this area, the Department of
Industrial Technology of the Ministry for Industry and Trade is investing
mainly in the field of alcohol fermentation, aimed at the production of fuel
146
alcohol and the genetic improvement of yeasts (direct fermentation of
starch to alcohol; this work is being carried out by the Institute of
Chemistry of the USP).
b.3 Raison with areas in which knowledge is generated, with a view
to providing conditions for the satisfactory assimilation and
dissemination of knowledge.
This being the case, the Department of Biotechnology of the Ministry of
Science and Technology sees itself as an agent of integration and co-operation
and acts as national co-ordinator of the Government’s biotechnology activities. In
this context it should be private enterprise which acts, with public-sector support.
a.1. guidance, co-ordination and stimulation of biotechnology
activities;
In order to give substance to this proposal for the integration of
scientific and technological development work, by complementing and
incorporating the other fields addressed by the Ministry of Science and
Technology (CNPq and FINEP), the Department of Biotechnology will have to
allocate some US$60 million for the period 1987-89 over and above the
biotechnology budgets of the other areas of the Federal and State authorities
(source: SBIO plan of objectives). Approval was recently given for the
allocation of resources for the award between now and 1989 of 4 650 grants in
the country and 2 700 abroad, with the aim of stepping up training of
researchers and technicians in biotechnology, at home and abroad.
a.2. supervision of national work in the sector, so as to take account
of the priority economic- and social-development programmes
in a long-term strategy;
One of the principal means of distributing the above-mentioned
resources will undoubtedly be the implementation of the Biotechnology
Integration System.
a.3. participation in production sectors, on a complementary basis, in
the national interest and/or in cases where private enterprise is
unable or unmotivated to act;
The Biotechnology Integration System (BIS) is a national technical
and scientific cooperation network which brings together, under a number
of subject headings, the centres of scientific and technological production,
devoted to the same line of research or the subsequent development of a
product or provision of services using biotechnology.
The policy proposed by the Department of Biotechnology, leading up
to 1990, assigns the following roles:
a)
Public sector
a.4. provision of guarantees for national production;
a.5. establishment of appropriate conditions for full scientific and
technological skills to be developed in the sector by the
strengthening of research centres and training of teams with
guaranteed resources for these activities;
a.6. stimulation and guarantees for the development of national
technology and the economic, financial and commercial
strengthening of Brazilian enterprise, to ensure that it can
compete on an open market.
b) Private sector
b.1 exploitation of the results obtained from technological research
in biotechnology, bringing products within reach of society;
b.2 suggestions to the Government, on an interactive basis, of the
areas most needing investment for national production;
147
The system will examine, on the one hand, the critical areas of
science and technology to be introduced in the country, with a view to
reducing the present difference in level between the national and
international contexts and, on the other hand, will have to bring existing
know-how in science and technology within the reach of the national
production sector, for the development of goods and products.
In this system, input data will be taken to be the information and
requests resulting from scientific and technological production, at national
and international levels, the production sector, the administrative authorities
and related institutions and, in particular, the directives issued by the
national government, as embodied in the state biotechnology programmes,
which are being implemented in various parts of the country, such as Rio de
Janeiro, São Paulo, Minas Gerais, Rio Grande do Sul, Parana and Bahia.
148
The input data also include those opportunities offered by international co-operation programmes, with special emphasis on horizontal cooperation, the main example of which, to date, is the Brazil-Argentina cooperation programme.
2.3. MEXICO
Rodolfo Quintero Ramirez
Rosa Luz Gonzalez Aguirre
At the operational level, the BIS will make use of BICs (biotechnology
integration centres).
BICs
will be structures for co-ordinating centres of acknowledged
research capability, organized at state or regional level, intended to support
biotechnology application projects integrated with the production sector.
The BICs will take part in the Biotechnology Integration System
within the context of activities and lines of research of national interest,
managing their activities entirely independently of the sys-tem as regards
local and regional integration initiatives.
The administration of the system will be the responsibility of the
Department of Biotechnology, and general coordination will involve full
representation of institutional bodies and the operational sectors.
The system will have a matrix configuration and will offer as output data
the products established in its planned objectives, with feedback based on a
system of continuous assessment, to be implemented by general co-ordination.
Therefore it is expected that, coupled with the other initiatives taken
at federal and state level, the biotechnology integration system will be a
key means of bringing about the quantitative leap that Brazilian
biotechnology needs.
Introduction
Biotechnology in Mexico is represented by a mixture of research and
development as well as industrial and promotional activities realised at
different levels of scientific and technological complexity. To evaluate its
development and position in the country as well as estimating the potential and
possibilities of technico-economic multi-lateral co-operation, it is necessary to
define and delimit this techno-logical sector using the parameters available.
The definition of biotechnology used in this document is as follows:
A multidiscipline which has evolved from the initial objective of
manipulating micro-organisms in the production of goods and ser-vices
to include the use of enzymes, as well as vegetal or animal cells,
aggregates or components thus amplifying its practical utilisation and
now including the modification of superior organisms such as plants
and animals. All this was made possible thanks to technological
breakthroughs such as: recombinant DNA, cell fusion, cell and protein
immobilisation, molecular synthesis with enzymatic characteristics
which have all reinforced fermentation technology, culture of plant and
animal cells and enzymatic technology(Quintero, 1985)
A classification of the different types of biotechnology is shown in
Table 1 (González and Zermeño, 1986; Quintero, 1985). Based on these
elements, the first part of this work presents a general view of the situation
in Mexico describing the biotechnological activity in research and
development, industry, vocational training and legislation.
In the second part, some potential options for technico-economic cooperation between the members of the EEC and Mexico are discussed within
the framework of shared interests and equality of rights and duties.
149
150
Table 1. Categories of Biotechnology
Parameter
First generation Second generation
Age
Scientific
Content
Technological
Content
Type of
organism or
its part
Origin of
Organism
Ancient
Elementary and
Advanced
Elementary and
Advanced
Modern
Elementary and
Advanced
Third generation
Alternative
Modern
New Application
Elementary and
Advanced
Advanced
Elementary and
Advanced
Micro-organism
Micro-organisms Micro-organisms
Plant cell
Animal Cell
Natural
Natural
Natural
Artificial
Farming and
Food, Chemistry
Forestry, Food
Health, Energy
Type of
Chemistry,
Food, Chemistry Agrochemicals,
product
Health, Energy,
Contamination
Contamination,
Control
Control
Control of nearly
Interaction
all variables that
with SocioControl of nearly Control of nearly all
can be influenced
Economic
all variables that variables that can be
The process is
setting and
can be influenced influenced
adapted to the
Environment
setting
Reduced,
Technology Reduced and
Reduced and
Intermediary and
Users
Intermediary
Intermediary
Intensive
Growth Level of
Growth Level of
Demand
Demand
Range of
Growth Level of Modification of
Modification of
Application Demand
Demand
Demand
New System of
New System of
Demands
Demands
Developed
Simple
Simple Complex
Simple Complex
Applications
Advanced
Source: González and Zermeño, 1986
151
Elementary
Micro-organism
Natural
Farming, Food
Energy
The process is
adapted to the
setting
Intensive
Growth Level of
Demand
Modification of
Demand
Simple
The Present Situation of Biotechnology in Mexico: Research,
Development and Industry
F IRST GENERATION INDUSTRIAL B IOTECHNOLOGY
Industrial biotechnology of the first generation constitutes the most
important category in Mexico in terms of market size. The main products
are fermented drinks, milk derivatives, cereal derivatives, industrial yeasts
for baking, alcohol (for industry or for consumption), acetic acids and
edible mushrooms (Table 2). The most important application of this type of
biotechnology is found in the fermented drink sector of which beer is the
greatest user (González and Zermeño, 1986; Quintero, 1985)
Research and development in this biotechnological technique is
scarce and production is oriented towards an internal market. Generally
speaking, traditional Mexican biotechnology in the last decades has been in
a state of saturation due to a sustained population growth with a better
standard of living and because international trade has been of a marginal
nature (González and Zermeño, 1986).
Despite the fact that there are different ranges of products, the traditional
biotechnology industry is of a strongly oligarchical nature. The competition
between these industries from one point of view and the actual maturity of
technology from another, has led the stronger enterprises to rationalise and
standardise production through more and more automated processes.
The most consolidated industries such as those for fermented drinks
like beer, wine products and liqueurs are important sources of employment
not only in production and distribution of these products but also of the raw
materials, and are factors of economic development of other products. This
industry has reached a state of prolonged saturation. Part of the industry
handles high production volumes which helps improve product quality and
productivity and which represent the most important conditions to maintain
and improve the internal market as well as to enter into international
markets (González and Zermeño, 1986).
152
Table 2. Mexican Biotechnological Industry
Category
Products
Companies
Beer
Cervecería Modelo
Cervecería Cuahutemoc
Cervecería Yucateca
Wines and brandies 68 companies
First generation Derived products
431 companies
Biotechnologies and milk products
Yeast for bakeries
Acidos Orgánicos, S.A.
Industria Mexicana de Alimentos, S.A. de
C.V.
Fleischman
Ethyl alcohol
Asociación Nacional de Productores de
Alcohol
Acetic Acid
Compañia Beneficiadora Del Coyol, S.A.
Antibiotics
Fermic, S.A. de C.V.
Orsabe, S.A.
Cyanamid de México, S.A.
Pfizeer, S.A. de C.V.
Centro Industrial Bioquímico, S.A.
Upjohn,
S.A. de C.V.
Second
Abbot
Laboratorios
de México, S.A.
generation
Sinbiotik, Beneficiadora e
Biotechnologies
Industrializadora, S.A.
Enzymes
Enmex S.A.
Velfer, S.A.
Pfizer, S.A.
*Genín, S.A. de C.V.
*Enzymóloga, S.A.
Amino acids
Fermentaciones Mexicanas, S.A.
Organic acids BioQuímica Mexicana, S.A.
fertilisers
Pfizer, S.A.
Nitragin, S.A.
Diamond Shamrock
Pagador
Química Lucava
Table 2. Continued.
Category
Products
Vaccines
Second generation
Biotechnologies
Third generation
Biotechnologies
Alternative
Biotechnologies
Micro-propagation
Methane
Silage
Cell usage
* Dedicated to technological development.
** Dedicated to the final packaging.
Source: Quintero, 1985
Companies
Gerencia General de Biológicos y
Reactivos
Laboratorios Dr. Zapata
Other companies**
Biogenética Industrial, S.A.
Mexicana de Propagación de
Plantas
Digestors exist in various parts of
the country
Various parts of the country
Various parts of the country
Such increments in quality and productivity could be achieved by
small technological innovations. These are likely to take place in the near
future since a number of fermented drink manufacturers have shown an
interest in national research groups working on solutions to service
problems in the industry.
The consumption of food products such as edible mushrooms and
milk derivatives can be increased by encouraging lower cost and smaller
scale production processes than those predominant in the country.
The culture of mushrooms and other macro mycological products can
be developed both for export and internal consumption at production sites
that make use of favourable climatic conditions and by intensively using
manpower (Leal, 1985).
It must be emphasised that the production of edible mushrooms
constitutes one of the rare possibilities of biotransforming lignocellulosic
residues without submitting them to a pre-treatment which is presently still
very expensive. This is of great importance because of the abundance of
this type of residue in the country (Table 3) (Leal, 1985).
The production of macro mycological products with this approach
requires that the culture technology is adapted to the local conditions from
the point of view of both availability and investment as well as cost and
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154
skill of local labour. The same applies to the development of new methods
for the preparation of substrates from local raw materials, new types of
materials and locally adapted climatisation (Leal, 1985).
Table 3. National Agricultural Production in 1978 (NPTSD, 1984)
Agricultural harvest
Production (tons)
Corn straw
16.613.532
Sorghum straw
2.492.874
Wheat straw
1.723.670
Bean straw
1.320.716
Sugar cane straw
1.205.557
Wheat husks and brans
750.172
Barley straw
534.746
Oat straw
131.321
Non-commercial fruit and vegetables
79.855
Rice husks
59.309
Peanut straw
43.379
Chickpea straw
25.134
Total
24.980.265
Source: Leal, 1985.
Milk derivatives such as traditional cheeses can be integrated into the
production of milk, which in turn forms part of the normal agricultural
production, through fermentative processes using the subproducts or the excesses
as forage. This improves the profit of small producers and reduces competition in
the production of the basic grains which form the popular diet (Viniegra, 1986).
The above implies the availability of specialised equipment, technical
assistance and a means of commercialisation for the small cheese cooperatives. These services are necessary to encourage and sustain the
production chain at an elementary technological level and include
information, transport and distribution methods in order to commercialise
the products in a way adapted to the local conditions (Viniegra, 1986).
SECOND GENERATION B IOTECHNOLOGY
This type of biotechnology is actively used in the production of
antibiotics, amino-acidic enzymes and in the treatment of effluents as
shown in Table 2. All the technology used comes from abroad (González
and Zermeño, 1986).
155
A well equilibrated investment in this category of global bioindustries
does not apply to groups of products in the same way. For this reason foreign
investment appears to dominate the area of enzymes and certain antibiotics.
However, there are national and public enterprises which are dedicated to the
production of amino acids as well as penicillin and some of its derived
products (Quintero, 1985).
Because of the international effervescence in biotechnology a number
of new, mostly small sized, national enterprises have appeared in this
biotechnical category (Table 4). It must be emphasised that newly created
enterprises have a more open attitude towards research and development
contrary to the vast majority of second generation biotechnological
enterprises in which this type of activity is almost non-existent.
Table 4. New Biotechnological Organisations in Mexico
Enzymology (Monterrey, N.L.)
Phenylglicina (enzymatic), phenylacetic
acid, phenylalanine and aspartame (of its
interest)
Bioenzimas (Saltillo, Coahuila)
Improved grains, insecticides, gibberellic
acids and other agricultural
biotechnological products (enzymes)
Industrial biogenetics (México D.F.)
Micropropagation of strawberries,
aspergus, Violet (tissue cultures)
Genín (México D.F.)
Technological development of
immobilised enzymes
Forestal Center of Genetics (Texcoco,
Genetics improvement and forest
Edo of México)
micropropagation
Source: Quintero, 1985
Research groups are concentrated in universities, centres and
institutions of higher education (Table 5). It is in this type of biotechnology
that the country has the largest and most qualified research group even if most
of its efforts are devoted to applied research and technological development.
However, no technological development in this area has been applied to
production methods (González and Zermeño, 1986; Quintero, 1985).
In the case of enzymes and new pharmaceutical products the
internal market is insufficient and the competition in international markets
is very difficult. With amino acids, the important conditions for
industrialisation exist but expansion presents problems with economic
156
resources. This type of problem also affects the unicellular proteins and
the microbial polysaccharides. In the case of xanthans, for example, the
technology has developed in this country and has reached a semicommercial level with a specific application for the product. However, at
a national level, there are insufficient economic resources to make use of
it even if it shows a high profitability in the current conditions in Mexico
(González and Zermeño, 1986; Quintero, 1985).
Table 5. University Research Centres with Adequate Facilities and
Experienced Staff
Genetic and Biotechnological Engineering Research Centre (UNAM), Cuernavaca,
Mor.; covers an area of 5.000 m². Areas of interest: genetic engineering and
biotechnology applied to health and food.
Research Centre for nitrogen fixation, (UNAM), Cuernavaca, Mor.; covers and area
of 4.000 m². Areas of interest: molecular biology and genetic engineering applied
to plant cells.
Research and Advanced Studies Centre, (IPN), Department of Biotechnology and
Bioengeering, México, D.F.; has an excellent pilot project facility and well
equipped laboratories. Areas of interest: fermentation and enzymatic engineering.
Research and Advanced Studies Centre. (IPN), Unit of Modern Plant Biology,
Guanajuato, Gto; covers and area of 8.000 m². Area of interest: conservation and
preservation of grains, genetic engineering applied to plant cells.
Research Institute of Biomedicine, (UNAM), México, D.F.; has an operational pilot
project and is generally well equipped. Areas of interest: industrial microbiology,
fermentation and enzymatic engineering.
Department of Biotechnology, UAM – Iztapalapa, México, D.F., has pilot project
facilities and good equipment. Areas of interest: food, transformation of substrates
via solid fermentation, water treatment.
Source: Quintero, 1985
Other countries show a great interest in acquiring this technology. This
could be very positive for national production to increase its confidence in the
local development and the resources obtained from royalties could be used to
finance national developments.
The lack of economic resources is critical within all categories of
biotechnology but particularly for second generation types as, even if they
have rapidly restricted themselves, they offer better short term possibilities
because of the world wide scale of development (González and Zermeño,
1986; Quintero, 1985).
157
T HE NEW OR T HIRD GENERATION B IOTECHNOLOGY
Micro-organism manipulation work is exclusively restricted to
research in centres and higher educational institutions. It is currently being
linked with industrial projects especially for the improvement of
pharmaceutical processes.
It must be emphasised that pharmaceutical products form the
objective of the majority of research projects. They are internationally
highly competitive with high development costs and require a long time
before commercialisation. Such projects are: human insulin, growth
hormones, some vaccines, diagnostical tests, interferons, etc.
There are many qualified research groups in the field of plant cells,
particularly cultures of plant tissues (CVT), in the country which, although
they presently work on micro-projects, could devote their work to topics of
importance in the agricultural sector. Two of the recently created
enterprises belong to the plant biology area which covers the
technologically less sophisticated aspects of CVT such as the micropropagation (González and Zermeño, 1986; Quintero, 1985).
The genetic engineering of plants is becoming a well structured
sector. A centre has just been opened and what is most important is the
integration of very high level human resources. For animal cells the human
and technical resources are scarce compared with the previous sectors and
they are mainly dedicated to the development and industrial production of
vaccines against measles and poliomyelitis but with some work on embryo
transplants at a commercial level.
These elements, even if briefly presented, allow the following
prospects for third generation biotechnology to be considered.
M ICRO -ORGANISMS
This sub-category could have an important role in the improvement
of micro-organisms both for known second generation processes and for
future modifications to processes used in the manufacture of existing
products. Both cases link the existing research groups in the country and
firmly localise their participation in the chain of complete biotechnological
processes. The second option requires an understanding of the present
158
productive methods and capacity in the technologies which are intended to
be substituted (González and Zermeño, 1986).
New products, and particularly pharmaceutics, have greatly reduced
prospects as the human and economic resources (especially the latter) are
limited and the risk involved in new developments is very high.
P LANT CELLS
Simpler applications such as micro-propagation of ‘cultivaresvaliosos’ have a considerable potential market because highly skilled
scientists are available to develop the techniques and, if moderately skilled
technicians are trained, the use of the available climatic conditions, the
market access and the cost of labour will enable the country to both
compete with external markets and open new markets. Also, the economic
resources required to make use of these productive activities are not
excessively high compared to those required by other types of
developments (González and Zermeño, 1986; Robert, 1985).
The production of ‘metabolites secundarios’ using plant cells in
biological reactors for the processing of raw materials of for agricultural,
food and pharmaceutical products is a sector in which highly skilled
scientists are available but in insufficient number to cover all the stages
necessary for complete technological development. Moreover, an adequate
infrastructure is needed to allow development to be taken beyond the
laboratory stage (González and Zermeño, 1986).
There are, however, important limitations related to the type of
products. For example: the development of new pharmaceutical products is
very expensive, very long, and involves many risks. The production of
natural substances for food use, such as flavours, aromatics and colorants is
less costly and faster than the previous processes but experiences high
international competition which demands a very careful selection of
development projects.
Without any doubt the most important potential application related to
plant cells is a genetic improvement. Both in Mexico and internationally,
agricultural production currently faces a series of limitations which are: a
lack of cultivable land, environmental stress, sickness and plague (González
and Zermeño, 1986; Robert, 1985).
159
For each of these limitations, plant biotechnology has an answer
which could be the development of varieties adapted to ever better
controlled conditions (which is not much different from the ‘green
revolution’) or varieties more and more adapted to socio-economic and
environmental conditions. This type of answer could revolutionise
agricultural production, have large repercussions on industry and the
economic and social activity of each country. This would particularly apply
to those less industrialised countries which, for their development
requirements and the diffusion of this kind of technology, could have access
to the benefits that the latter could relatively easily provide (González and
Zermeño, 1986; Robert, 1985).
In the particular case of Mexico, the conditions allow both solutions to
be applicable. There are highly qualified scientists available who can develop
either of the technological solutions. The food policy adopted will determine
which solution will be emphasised (González and Zermeño, 1986)
Before ending this topic, it is very important to note that genetic
manipulation research groups are aware that they do not replace the
traditional work of agronomists and botanists. For this reason, a contact
with them is being sought and mechanisms are being pre-pared to promote
interdisciplinary research.
Finally, the existing animal cell groups, even if very scarce, have
extensive experience in producing vaccines and they have recently
succeeded in using a national development for the industrial production of
anti-measles vaccines with diploid cells and are actively working to modify
the production of polio vaccines (the diploid cells instead of monkey renal
tissues). The experience of these groups forms an excellent basis for the
promotion of this sector especially for the improvement of processes.
ALTERNATIVE B IOTECHNOLOGY
Less conventional biotechnologies, which try to use residues in order
to produce biogas or cattle feed, should also try to solve the problems of
regional contamination caused by specialisation in cattle and agriculture.
However, the scale of production must be maintained in order to reach
intermediary dimensions. To presume that these biotechnologies exist in the
rural environment only at the level of one or several families is very
optimistic (González and Zermeño, 1986; Quintero, 1985).
160
From this viewpoint, alternative biotechnology is better considered as
a subcategory of all other biotechnologies rather than a separate category in
which its scope of application would be very limited and the technological
content more basic (González and Zermeño, 1986; Quintero, 1985).
Based upon previous success, the development and growth potential
of certain biotechnologies applied to aquaculture, the cultivation of
mushrooms or other species and food processing will be stimulated as
conventional technology is more compatible and the impact much greater.
What is most important is to acquire experience and create a basis to be
able to benefit from the possibilities offered by biotechnology. This also
means a change in the tendency towards specialisation. As long as diversity
is increased by more integrated processes which are less intensive in capital
and energy and more adapted to the environment, the profits related to the
scale of production will be less and less important and the level of
development of the country will be raised with less socio-economic and
environmental costs than the current mode of development (González and
Zermeño, 1986; Quintero, 1985).
Vocational Training
The history of scientific training in biotechnology in this country
dates back to the second half of the thirties at the time when the studies of
enzymology and biological chemistry were created and oriented towards
industrial biological processes. Both studies later became biochemical
engineering (1957). Nowadays, a degree in biochemical engineering can be
obtained at more than twenty educational institutions distributed throughout
the country (Quintero, 1985, 1986).
Postgraduate training began early in 1970 and the seven institutions
which offer such courses are fisted in Table 6. All offer master of science
degrees and, recently, two of them offer doctorates. Most of the
postgraduate programmes cover the most general sectors of biotechnology
(fermentation and enzymatic technology, genetics and genetic engineering)
and two are dedicated to plant biotechnology. At first degree as well as at
postgraduate level the main subjects are oriented towards the food sector
without particular specialization (Quintero, 1986)
161
Table 6. Postgraduate Biotechnology Programme (Leal, 1985)
No. Institution
Programme
1. Research and Advanced Studies Centre/D.F.
Biotechnology
2. Research and Advanced Studies Centre/D.F.
Biotechnology
3. Research and Advanced Studies Centre/Irapuato
Biotechnology
4. Technological Institute of Mérida/ Scientific
Biotechnology
Centre of Yucatan
5. Technological Institute of Veracruz
Biotechnology
6. Technological Institute of Veracruz
Biotechnology
7. Research Institute of Biomedicine, National
Biotechnology
Autonomous University of México
Degree
M
M
M, D
M
M
M
E, M, D
E = Technical training
M = Master’s degree
D = Doctorate
Source: Quintero, June 1986.
Historically, vocational training in biotechnology has only covered
biochemical engineering with postgraduate degrees in biotechnology and
bioengineering but the available number of positions related to biotechnology
is much higher in the country. In plant related biotechnology there are more
than 100 higher education establishments for agriculture and biology with an
equal number of experimental sectors.
There are several institutions which offer a master’s degree in a
speciality linked to biotechnology and which have had doctorate
programmes in biochemistry, cellular and molecular biology, genetics,
microbiology, chemistry and biology. Moreover, since the Mexican
government considers biotechnology as a priority sector, it assigned special
resources for all of the scholarships granted in 1985 for postgraduate study
abroad by the National Council of Sciences and Technology (NCST) of
which 17% corresponded to biotechnology.
The basis of the above indicates that degree level training in
biotechnology is actually based on the possibilities of absorption by the
existing biotechnological industry which requires technicians of an average
level of education. In the case of the first generation, the specialised
technical assistance is obtained from abroad through suppliers of machinery
and equipment; in the case of the second, most enterprises are branches of
multinationals which import this technical assistance and, as far as both the
162
third and alternative ones are concerned, they are non-existent. (González
and Zermeño, 1986).
Finally, at postgraduate level, the system is new and has produced in
the last ten years more than twenty master’s degrees in sciences and more
than forty without any degrees. An exhaustive diagnosis was recently
completed in the food sector in which biotechnology is included for
practical reasons. As a result of this work, specific recommendations have
been made for each of the postgraduate programmes in the country relating
to food with the expected result being a sharp increase or development in
the short or middle term of this level of biotechnology. Relative to this, it is
important that scientific training at a national level must be directed towards
the interdisciplinary work and to the development of integrated
biotechnological processes through educational programmes and research
linked to the production sector (VTG, 1985).
Legal Aspect
The country’s legal requirements relating to technological and
economic multilateral cooperation are: patent and trademark laws, laws
relating to registration and control of technological transfer and those
concerned with foreign investment.
The patent and trademark law dates back to 1976 and has recently been
reformed and expanded partly in dose relationship with biotechnology.
According to Mexican law the following are not subject to patents:
1. The plant and animal species, their varieties, and the essentially
biological processes necessary for their creation, including those of
a genetic type.
2. The biotechnological processes for pharmaceutics, general medicines,
drinks and food for animal consumption, fertilizers, anti-plague
products, herbicides, fungicides or biologically active products.
3. Chemical products, chemico-pharmaceutics, general medicines, food
and drinks, food for animal consumption, fertilizers, herbicides,
fungicides and biologically active products.
4. Food and drinks for human consumption as well as processes to
obtain or modify them.
163
According to the present Mexican legislation, a patent does not cover
biotechnological processes and products; however, it is possible to obtain a
certificate of invention for processes and products mentioned in paragraphs
b) and d).
The invention certificate is a non-exclusive right granted by the
Mexican State for a period of 14 years to allow the holder to commercialise
an invention. Anyone else who is interested in commercialising the product
pays the certificate holder the corresponding duties. This certificate is used
when a patent is not granted because the invention is of social benefit where
a monopoly is not permitted.
The invention certificate allows royalty payments to be made even if
it is not possible to practically apply the invention because it does not
oblige the exploitation of the invention.
This is not the same with a patent where exploitation of the invention
should start within three years from the date of it being granted. If it is not
exploited, the patent becomes invalid and the invention becomes part of the
public domain.
Mexican law states that one can register a certificate of invention
concerning any invention susceptible to be protected as a patent. This has
been done to give an incentive to individual creativity via advantages and to
protect the rights of research and development workers who are
concentrated in universities. If the only means to protect their inventions
was through patents, they would lose their rights if they did not manage to
exploit them within a three-year period.
Technological transfer in Mexico is regulated by laws covering the
control and registration of the transfer of technologies and the use and
exploitation of patents and trademarks (LCRTT). The main objective is not
exclusively to maintain control over technology transfer but also to ensure
that its own technological work is promoted. The organisation responsible
for the enforcement of this law is the Secretariat for Commerce and
Industrial Promotion (SCIP), which controls the National Register of the
Technological Transfer (NRTT).
Item 2 of this law catalogues the legislation used within the
national territory where registration is compulsory. Those related to
technical and economic multilateral co-operation in biotechnology are
164
presented in Table 7. These acts or agreements are covered by Mexican
laws, by treaties or international agreements of which Mexico is part and
which are applicable to the case.
Table 7. Licences, Contracts and Activities Related to the Multilateral Cooperation in Biotechnology that have to be registered with the ‘RNTT’.
– Licence for use or authorization for improvement or exploitation of an invention
which is patented or covered by an invention certificate.
– Licence or authorization to use commercial names.
– Communication of technical knowledge through plans, diagrams, models,
instructions, specifications, personnel training and education or any other means.
– Technical assistance of any type.
– Provision of basic or detailed technical assistance.
– Operational services or company administration.
– Advising, consulting and supervising services if controlled by foreign nationals,
or their representatives, independently or their residence.
– Computer programs.
The following are required to apply for registration with the NRTT:
Mexican nationals as well as foreigners living in the country, foreign
agencies or foreign branches established in Mexico as well as nationals
residing outside the country but who are involved with agreements or
contracts which affect the country.
Registration is necessary to be able to benefit from the profits, the
encouragements, the assistance or the facilities foreseen in the
governmental plans and programmes, as well as for the establishment or
expansion of industrial enterprises. The legislation contained in article
number 2 which has not been registered with the NRTT (or which has been
cancelled by the SCIP) is null and void and cannot be made valid in front of
any authority and its application cannot be requested by the national courts.
The law also provides a chapter covering the causes allowing the
NRTT to reject an application for the following reasons: the protection of the
applicant regarding any detriment to his financial situation, his
administrative autodetermination or any restriction to his R&D activities.
Within the legal framework, and in policies directly related to foreign
investment, the law enforced since 1973, which promotes Mexican
investment and regulates foreign investment, together with the policy of
165
selective promotion of foreign direct investment, which started in 1984,
clearly promotes the direct foreign investment in biotechnology. From this
viewpoint, it is important to note that one of the most regulated foreign
investment sectors, that of secondary petrochemical derivatives, has
recently been freed from the restriction of using national capital for the
majority of investments relating to the expansion of the range of products.
Current technological advances (including biological technology) have
made this possible using either different processes or raw materials which
are not petrochemical. In Figure 1, the percentage participation of foreign
direct investment is presented according to the country of origin.
Options for Technico Economic Co-operation
Biotechnology has direct applications in most of the sectors of economic
activity and can be used at different scientific and technological levels with a
variety of raw materials for similar types of products. This results in a group of
technologies with different characteristics and requirements and with a
tendency for interchange between them. The countries meeting on this
occasion are all at different levels of technological advancement. For this
reason it is important to consider any proposal related to these differences
and this is why the possibilities of application of the various options are
closely related to the scientific and technological capacity of the
participants and to the level at which their political, economic, and social
interests can merge.
1984
United States
Federal Republic of Germany
Japan
Switzerland
Others
%
66,0
8.7
6.3
5,0
14,0
1985
United States
Federal Republic of Germany
Japan
Switzerland
Others
%
67.4
8,0
6.1
5.3
13.2
Sources: SCFI, 1986
Fig. 1. Foreign investment per country of origin (percentage)
It is important to underline that, in Mexico, studies have been made
for some time to define the sectors which require efforts to be made to
develop and diffuse biological technology whilst taking into account the
requirements, the scientific and technological capacities, the economic
166
resources and the availability of raw materials (González and Zermeño,
1986; Quintero, 1985, 1986).
The establishment of priorities was no easy task for a country with
the population size of Mexico. However, it has become apparent that the
multitude of applications made possible by biotechnology cannot be coped
with simultaneously. Accordingly the applications selected for a recent
study on the evaluation of opportunities in biotechnology, which was
financed by the National Council of Science and Technology, are: food,
agriculture and health (Quintero, 1985, 1986).
Taking into account the above factors and other elements considered
as important for the scientific and technological policy of the last 15 years
in order to make sure that research has an economic and social impact,
(NPTSD, 1984; NPST, 1978) as well as the situation concerning biotechnology,
(Quintero 1985) we consider that the following types of co-operation are the
ones which would have the greatest potential for success.
Vocational Training
High level technical training is mainly oriented towards interdisciplinary
education and research programmes which integrally cover the different
stages of the development process of biological technology. The sectors
which should be mostly emphasised are: design, sizing and operation of
biological reactors as well as recuperation and purification of products. This
type of training should preferably be given in research laboratories of the
production sector as well as in technological development centres.
RESEARCH AND DEVELOPMENT
R&D collaborations should be aimed at the realisation of research
projects in previously mentioned applications. The possibilities offered by
biotechnology for the co-existence of differing levels of technology would
allow different countries to participate in precise activities throughout the
project according to their respective scientific and technological capacities.
As a consequence, third generation and alternative biotechnology provide
several applications in which the processes must be adapted to socioeconomic and environmental conditions, and in which some of the stages of
the project must be realised at the site of the application.
167
To take care of this, the country has provided research and
technological development centres with experience in pilot and commercial
level projects allowing specific agreements of collaboration to be agreed.
Some of these centres have highly qualified staff who belonged to
international research groups at the time these groups were realising
considerable achievements in third generation biotechnology.
APPLICATIONS IN P RODUCTION
Establishment of new undertakings in selected applications. The most
appropriate option for multilateral co-operation is considered to be joint
ventures as this would imply an intermediate investment level compared to
the establishment of a branch and the financial risks would be shared.
This option not only allows the partners to share the technology, but
also offers the possibility of gathering together human, technical and material
resources to continue with research and development activities. In our opinion,
this is very similar to previous statements that multilateral co-operation should
be founded on shared interests and in a mode of equality of rights and duties.
Finally, the options for co-operation that have been mentioned in the
case of Mexico should be based on third generation and alternative
biotechnology. The advantages and the disadvantages of the analysis of
some of these options is shown in Table 8.
Table 8. Types of Associations for the Production Sector.
Type
Advantages
Disadvantages
Association
Cost and risks are low for the
Financial profits limited for the
via licence
technological partner.
technologist
Risk that the technology is not
Greater control for the financial
adequate for the socio-economic
partner
and environmental conditions
Joint ventures
Shared financial risks
Whatever disadvantages remain
Access to patented technological
after defining the following:
information.
– Proposals
The optimization of resources to
– Objectives
develop new technologies.
– Contribution of each party
The access to reputation, market
– Adequate methods to evaluate
distribution network and
tangible and intangible assets
knowledge of local culture.
168
Bibliography
Vocational Training Guidance, Conacyt, ‘Evaluatión de programas de posgrado del pais, en la área de alimentos’, México, D.F. January 1985.
González, R. L. and R. Zermeño, ‘El desarrollo tecnológico y su
promoción’, ‘El caso de la biotecnologia en México, presented to the
Cuban Seminar II on the interferon, at the Cuban Seminar I on
Biotechnology, La Havana, February 22, 1986.
Leal, H., ‘La utilización microbiológica de desperdicios lignocelulósicos.
Potencialidades y perspectivas’, in R. Quintero (Ed.), Prospects of
biotechnology in México, Foundation Javier Barros Sierra and the
National Council of Sciences and Technology, México, 1985, pp. 93114.
Robert, M. L., ‘El Cultivo de tejidos vegetales en México’, in R. Quintero
(Ed.), Prospects of biotechnology in México, Foundation Javier
Barros Sierra and National Council of Sciences and Technology,
México, 1985, pp. 367-373.
SCFI, ‘Panorama de la Inversión Extranjera en México’, Department for
Social Communication, México, 1986.
Viniegra, G., ‘La biotecnologia en la agroindustria alimentaria’, in R.
Quintero (Ed.), Prospects for biotechnology in México, Foundation
Javier Barros Sierra and National Council of Sciences and
Technology, Méidco, 1986, pp. 115-130.
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Sciences and Technology, México, 1978.
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Quintero, R., ‘Biotechnology in México: Needs and opportunities’,
presented at the Symposium: Development, Achievements,
Aspirations and Problems of the Biotechnological Sciences in
México, organised by The Society for Industrial Microbiology, 43th
Annual Meeting, San Francisco, California, August 11-15, 1986.
Quintero, R., ‘El desarrollo de la biotecnologia en México: Evaluación de
Oportunidades’, National Council of Sciences and Technology (in
preparation).
Quintero R., ‘Prospectiva de la biotecnologia en México’, in R. Quintero
(Ed.), Prospects for biotechnology in México, Foundation Javier
Barros Sierra and the National Council of Sciences and Technology,
México, 1985, pp. 461-468.
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169
170
2.4.1. Andean Technology Policy: Its Nature and Far-Reaching Effects
This instrument eventually became one of the most typical
contributions of the Andean Group. As a matter of fact, through their
execution it was possible: to constitute multinational teams of experts and
technicians; to obtain external financial resources; to reduce the differences
among the projects; to exchange specialized information; and, to develop
new techniques and methods for technology transfer.
The Technological Policy adopted in 1969 by the Andean Group
(GRAN), was defined to handle the demands generated by the economic
integration process, whose goals were: the opening of possibilities to link
technology to the building of a large market, the subordination of foreign
investments and technology transfer to national and subregional interests
and to link technology to the very process of production and services as one
of its main factors.
As indicated before, the Andean Technological Policy was steered to
demand knowledge from an ambitious project of subregional industrialization
and a growing market. However, the far-reaching effects of a joint
industrialization were partial and could not cope with the proper
characteristics of an incomplete industrialization of the Latin-American
region. The enlarged economic space, a key factor for technological
development, did not trigger the expected demand of technology.
The Andean Technological Policy was an essential element of the
idea which tried to assert a process based on domestic habilities, displaying
its own capacities and promoting the utilization of local production factors
as an important component of an independent development model.
Handling problems related to foreign investment, patent rights, technology
transfer, information, permitted a step forward to the understanding of the
matter. It also made possible to enact new rules on these matters allowing
the definition of the action to stimulate technological development.
The strategic scope established by the Technological Policy of the
Andean Group intended the combination of many financial, commercial
and fiscal elements, but there were multiple divergences among the public
powers, and between them and the private sector – a very common problem
in the Andean countries. The lack of concertation seriously restrained the
complete application of the Andean Technological Policy.
2.4. THE ANDEAN COUNTRIES 1
B. Carlos Aguirre
The Andean Programmes for Technological Development (PADT’s)
are the tools of the Andean Technological Policy and have become a new
experimental area within the GRAN (Andean Group). Thanks to their
execution, it was possible to realize that the integration process can take
upon itself different co-operative forms to reduce the possibilities of
conflict that can arise because of the complementarity that creates them.
They lead to the interaction and the union of efforts that outline the Andean
Group as a new unit of international co-operation.
1
This document was prepared for the European/Latin-American Seminar on Biotechnology
which, under the auspices of the European Economic Community, held in Brussels,
Belgium, between the 27th and 29th April 1987. This document represents the opinions of
the authors and does not necessarily reflect the views or opinions of the Cartagena
Agreement, nor those of the member countries of the Andean Group. The present document
is based on works done by experts of each Andean country, propositions by the Cartagena
Agreement to the Andean Council of Science and Technology, and the results of a cooperation programme carried out since 1975.
171
2.4.2. Guidelines for a Reorientation of the Andean Scientific and
Technological Integration
NEW CHALLENGES
The application of the Andean Technological Policy advanced with
the achievements and limitations already noted. In the meanwhile, and after
a period of dynamism and growth, the integration process went through
phases of stagnation and even regression.
Simultaneously, there is an unprecedented acceleration toward the
technological change in the more developed countries, favourable to the
upheaval of a new pattern of industrialization which tends to ignore the
comparative advantages of developing countries.
On the other hand, as a counterpart to the crisis, the modernization
gaps within the countries constitute a great challenge from social,
productive and technological points of view.
172
In spite of the growing attention placed by the governments of the
Andean countries on science and technology, the answers are still
insufficient for a National Policy to face problems such as those cited. The
new technological elements playing a role deepen the differences between
the Andean countries and the more developed countries. The intrinsic
weakness of the existing scientific community, the fiscal crisis and the
public debt, exacerbates the brain-drain and the dismantlement of the subregion’s research centers.
Reorientation of the Scientific and Technological Integration: Bases for a
New Concept of Joint Action
A series of orientations directed to consolidate the obtained results,
overcome limitations and face the new challenges at national, sub-regional
and international levels, have occurred over the last three years in the
Andean Group.
The ‘Reorientation Programme of the Andean Integration Process’
(1983) contains a conceptual basis that should be mentioned. It points out
that integration should offer the countries new prospects and alternatives for
their development processes in fields necessitating efforts beyond the
national boundaries and, therefore, requiring to be approached by a joint
and concerted action. It also underlines the necessity to work with a flexible
and pragmatic criterium in order to complete the application of the existing
tools with all the possible forms of co-operation leading to a major
interrelation among the countries.
Science and technology will help the development of this idea of
reorientation. Two central aims are at the base of the new Andean
technological strategy:
a) ‘To create a joint capacity of scientific and technological response
to the challenges of the countries’ development and subregional
integration process’
The problems, already described, show the advantages of
association. The current crisis makes it urgent to unite efforts. In the
technological field, it is more and more obvious that isolated positions
are insufficient. A joint action is the new support for integration.
Besides, scientific and technological co-operation is a must for the
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Andean countries, since none of them can establish an independent and
viable scientific and technological community.
It is worthwhile to insist here upon the elements of an Andean
scientific and technological community. To achieve this, it is imperative to
combine human, institutional and financial resources, not only those of the
member countries, but also those of an international cooperation.
A pragmatic and urgent effort of permanent harmonization must be
made to identify areas susceptible of integration.
b) ‘To contribute with science and technology to the carrying out of
sectorial strategies for the Andean integration process’
The sectorial strategies for integration enable to identify scientific and
technological requirements. From them and through adequate programming
and planning, the appropriate mechanisms and instruments to them can be
recognized. Among the strategies, the following should be mentioned:
Food safety, within it new prospects for research and application of
biotechnology: improved seeds, production of animal vaccines, nitrogen
fixation, development of a variety of plants resisting diseases, etc.
Different political decisions give priority to the necessity to develop,
appraise and protect renewable and unrenewable natural resources.
On the other side, the industrial sector strategy points out common
methods to develop the agro-industry sector. This is due to its potential not
only in the expansion of the production of existing goods, but also in the
incorporation of new products responding to the basic needs of
consumption, and the restriction on imports of final products and basic
materials which can be substituted by subregional natural products.
The capital goods sector, a little behind but having a great potential
for development in the subregion. It must be taken into account because of
its implications on the use of skilled labour, major autonomy of industrial
development, commercial potentiality, margin to continue the substitution
of imports, and beginning exports on an extended market.
Electronics and telecommunications sector. Because of its numerous
links to other areas, such as industry when it results in capital goods, it is
one of the ‘most promising’ themes to work on science and technology.
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Priority is given to the evaluation of potential partners investing on projects
for development and production of equipment and the constitution of
Andean multinational enterprises.
2.4.3. Fields of Action of the New Andean Technological Policy
To reach the enumerated goals, the Andean Strategy for Scientific
and Technological Integration has suggested a series of policies focused on
fields of action that permit a kind of viable programming, that is to say
ready to be applied under Andean realities. The carrying out of these
policies should integrate efforts and resources around key matters, and give
to the Andean Group a more specific outline when working on science and
technology, and using for its development the economic space of the five
member countries. Thus, new opportunities are open because of the
deliberate utilization of a subregional space for products and sectors –
carriers of technology.
Three areas of action have been defined and will permit the
organisation of the GRAN’s efforts on science and technology:
A) M ANAGEMENT APPLIED TO THE DEVELOPMENT OF TECHNOLOGICAL
INNOVATION
The lack of an adequate management makes it difficult to apply
technology to production. What has been tested is more intuitive than
systematic. At present, it is clear that to obtain a real benefit from the
research results, it is necessary to combine commercial, financial, etc.
market mechanisms, as well as feasibility studies and technology transfer.
This stage will require higher expenses. ‘The enterprise, in general terms,
must play the role of a technological innovation promoter and open the
access to more appropriate and modern technologies’. It must be said that
without an improvement of the management applied to innovation, no
concrete results can be obtained.
B)
T ECHNICAL AND INFORMATION AREA
As indicated by the Andean Strategy for Scientific and Technological
Integration, one of the areas requiring a major emphasis is the one which
will permit ‘to collect, process, and offer to the countries technical and
economic information at subregional and international levels’…‘to prospect
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on trends of technical and economic change through branches and products’
and ‘to support the strategical thought of the subregion’.
Confronted with technical change, it is necessary nowadays to adopt
a watchful and prospective attitude, more rigorous, exigent and permanent,
as part of the subregional strategy, including the setting up of alternative
models for development, taking into account the new technologies and the
availability of subregional natural resources. The definition of best elements
in order to determine a future technological pluralism, must consider the
improvement of traditional technologies.
It has been underlined that ‘the creation of information susceptible to
support the concrete decisional process, in the pre-feasibility studies, is of
vital importance. It requires the combination of structured information on
alternative technologies, their economy and their economic conditions of
access. This information is not spontaneously available. It must be created.
Data must be organized to produce information, and so to say, likely to
modify representations and behaviours. The constitution of technical,
commercial and economic information must be made at the very foundation
of the new activities.
C)
SCIENCE, RESEARCH AND ADVANCED T ECHNOLOGIES AREA
The present scientific and technological revolution is influencing
multiple aspects of production, health, education and services, which are
matters, because of their nature, of great interest for the Andean Group.
The encouragement given to science in the subregion acquires a
different perspective. It becomes the condition to assimilate the present
current of technological advances. There is talk of an industry based on
science. The development of intellectual factors will be the key of
competition between countries and group of countries. In the more
developed countries, the scientific policy is gaining consideration after a
period of stagnation.
In the light of a series of new demands that the sectorial strategies of
the Andean Group would lay on scientific and technological areas, it is easy
to remark that it is impossible to step forward without a good dose of
organization, programming and effective support in the field of personnel
training and its utilization through research activities.
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The ‘Caracas Programme’, approved by Decision 183 of the
Cartagena Agreement Commission, claims to fulfill the void on those
matters, setting up arrangements and compromises through harmonization
and concertation.
A proposition of interest consists of structuring around the
Programme a strong supporting movement to the scientific disciplines that
serve as a basis for advanced technologies, depending on common needs,
that is to say, scientific research and training of personnel.
Therefore, the human resources policy becomes a ruling principle of
the Andean strategy as announced at the Cartagena Agreement, ‘…the
unique policy compatible with a shifting future and the dynamics of the
technical change, is the training of specialists who should be given a solid
scientific knowledge and good practice in research methods. These are the
right tools that will enable a fast adaptation to scientific changes,
technological innovations and exchange of researchers…’
2.4.4. The Andean Programme of Biotechnology
research institutes. Special attention will be placed on problems such as
technology transfer and intellectual property.
The programme must consider the degree of advancement of the
results already obtained in the Andean countries. Information on
opportunities and sources, where a subregional action is advisable, will be
collected and analyzed. The programme’s basic activity is the analysis and
evaluation of economic, technical and commercial information.
An immediate requirement is to promote the education and training
of personnel research techniques. The establishment of networks and
specific projects of R&D is part of the initial effort to identify requirements
and common means for training.
2.4.5. National and Subregional Experiences
N ATIONAL EXPERIENCES
The outline of the Andean Programme of Biotechnology is based on
the experience of each member country in the biotechnology field.
The Cartagena Agreement has promoted since 1986 the programming of
the Andean Strategy for Scientific and Technological Integration in concertation
with ruling organisms of scientific and technological policy of the member
countries, which constitute the Andean Council of Science and Technology.
At national level, there is a group of important activities in execution
or planned at short or middle term, not only to formulate policies but also
programmes and projects.
The new stage, expected to be started in 1987, proposes to re-appraise
the meaning of integration, especially its potential economic space, as a
means to promote technological innovation within the subregion and to use
this process to fortify the Andean integration.
The development of biotechnology in Bolivia has not so far reached the
level of the other countries of the subregion. However, at the Academia
Nacional de Ciencias and the Universidad Boliviana, there is a group of
researchers working together with those of the private sector, which constitute
the basis on which a short-term nationwide programme is being discussed.
The effort displayed till now to structure the Andean Programme of
Biotechnology is an important part of the framework. To this purpose, there are
national and community experiences, which will be analyzed in this document.
In general, the programme will try to organize joint capabilities on
Biotechnology, especially in areas of social and economic interest to the
Andean countries, such as the agriculture, health and food safety areas.
In the management area of biotechnology innovation, the programme
will include financial incentives and a growing market. These actions allow
the promotion and establishment of Andean multinational enterprises or
similar forms of association, with the participation of the private sector and
177
B OLIVIA
It is convenient to indicate as background that various efforts have
already been displayed to establish a critical mass of re-searchers on which
the programme will be based on.
Particularly, the activity developed by the National Co-ordination
Committee for the development of biological sciences, has increased the
scientific level of experts on biology through national and international
courses and lectures, fellowships and training. At present, there are in
Bolivia experts concentrated mainly at Instituto de Genética Humana,
founded in 1972, Instituto de Investigaciones Biológicas of the Academia
178
Nacional de Ciencias, founded in 1961, Department of Biology of the
Universidad Mayor de San Simón and at the Facultad de Bioquímica y
Farmacia of the Universidad Mayor de San Andrés.
At the industrial sector level, the pharmaceutical industry, although
in the initial phase of formation has an important potential within a reduced
number of national laboratories: INTI, VITA, ALCO, SIGMA and others, which
have a high technological level. In the pharmaceutical field, Bolivia can
develop biotechnology for the production of antibiotics through available
natural resources.
There is also an important potential for biotechnology development
and its application on farming. On the other hand, within the framework of a
subregional project, Bolivia acquired important experience in the application
of biotechnology to the mining and metallurgical sector.
Within the framework of policies and strategies for the development
of the biotechnology programme, the Academia Nacional de Ciencias of
Bolivia proposes to prepare the right ground for the management of a larger
international co-operation, both regional and North/South, according to the
programmes previously developed by CONDECIB and enlarged with new
specific projects, which will integrate the scientific development sectors to
productive areas of the nation.
The specific projects will constitute a coherent whole through which
products and services of national and subregional interest will be obtained.
They will contribute to the development and strengthening of science in the
country and the Subregion.
The basic activity of these programmes or subprogrammes will be
made up of specific projects for research and development of products and
services. The programmes will be carried out by means of subcontracts
between both the ruling and the executive organisms.
In its initial phase, the programme will analyze the establishment of
an information network, the development of legal tools permit-ting the
protection of the obtained results, and the organization of biotechnology
laboratories so as to increase the interactions among them.
The general goals of the programme will be:
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a) To promote integration and links among the activities to be
developed on biotechnology in the country, allowing the technological advance for development, implementing the definition and
execution of biotechnologies and supporting the definition and
execution of joint actions in order to find solutions to local and
regional priority problems, through the obtainment of process
products and services.
b) To generate projects of regional interest, which will permit the
obtainment of international funds in order to try to solve the
problems which action will have to face within the national borders,
giving a remarkable social and economic impact enabling to clear
up and solve problems through biotechnology techniques.
c) To develop diffusion and demonstration mechanisms directed to
both state-controlled and private companies in order to promote
investments.
d) To fortify the scientific and technological infrastructure of the country
in order to carry out the programme for the benefit of Bolivia.
Regarding present research work in Bolivia, the Instituto de Genética
Humana is carrying out a research programme, sponsored by the O.E.A., on
Americanae Camelidae with the objective to implant vicuna embryos in
llama uterus.
Another programme, in execution at the present time, is molecular
biotechnology on diarrhoea diseases (enteropathy) and the transmission of
viruses; to combat the drug resistance of the pathogenic strains through plasmids.
The Instituto de Biologia of the Academia Nacional de Ciencias, is
carrying out a study on the neurobiological effects of snake venoms, and
later, will prepare serums and vaccines.
COLOMBIA
The National Programme of Biotechnology set up by COLCIENCIAS
endeavors the creation of a working mechanism with a high degree of
participation and consultation with both the scientific community and the
national productive sector. It also attempts the establishment of relations of
active exchange and co-ordination with other countries of the region which
have similar problems as those of Colombia, and also with countries in
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which biotechnology is well developed, marking the international trends
whose social and economic impact must be analyzed and made known at
the right time.
The basic activity is the permanent evaluation of the programme’s
progress, the redefinition of its objectives and priorities in accordance with
the results, new trends, identification of needs, studies of feasibility and
new opportunities.
The programme’s basic activity as well as the whole series of
necessary and essential activities for its perfect development, must rely on
sufficient financial and human resources besides a definitive planning in
order to reach the objectives. For this reason, each one of the essential
activities has been structured as a subprogramme defined with concrete and
specific goals and its proper order of priorities to give an answer to the
needs of the Nationa1 Programme.
Another of the Programme’s essential actions, already structured as
subprogramme, is the establishment of an interaction between the
productive sector and the scientific and technological sector. To fulfill this
requirement it is necessary to undertake an aggressive policy of reciprocal
diffusion between both sectors by means of a series of seminars attended by
international experts, and later on, to promote activities resulting in an
effective transfer of knowledge, technique, methods and services between
the sectors above mentioned.
Concerning the international relations, the corresponding subprogramme promotes the exchange with outstanding centres, binational and
multinational projects which encourage the national research activity,
courses, congresses, and any other scientific meeting in order to satisfy
specific needs of the research groups; organizes and diffuses any
information received from abroad and from international organisms to the
scientific community of the country; establishes contacts with technical
missions of the embassies and, through them with other science and
technology organisations of the countries represented; and keeps an active
relation with regional and international programmes on biotechnology.
Up to now, the following activities have been considered as
necessary for the efficient execution of the research projects:
b) Establishment of a scientific and technological information and
documentation network.
c) Setting up and running of a system of evaluation and control of the
programme’s development and other projects.
d) Monitoring and analysis of world-wide development trends of
biotechnology, and anticipation of its economic impact.
e) International relationships and regional integration. Co-ordination
with other national programmes.
f) Setting up and running of communication mechanisms between
both the scientific and technological and the production sectors.
Encouragement of a university/industry co-operation.
g) Enterprise management and development.
h) Projects for scientific and technological development.
i) Economic projects.
Each one of the activities mentioned above will give their support to
research projects. The activities have been chosen after consultation with
the scientific community and some representatives of the national
productive sector according to the country’s needs and priorities and the
presence of active groups in the different areas (see Chart 1).
The establishment of priorities for the development of biotechnology
products and their production at commercial level, should be based on detailed
economic surveys and on the predominating needs of the country and region.
Studies envisaged by the National Programme will start soon.
However, there are certain product lines and services unquestionably
essential because of their strong demand or immediate application and,
therefore, receiving financial support from COLCIENCIAS through specific
projects for development and research, which will be at short and middle term
the object of negotiations for technology transfer and adaptation.
These lines are: development of vaccines; production of antigens,
monoclonal antibodies, diagnostic kits for tropical diseases; plant
micropropagation through tissue or cell culture; improvement of the
symbiotic and asymbiotic fixation process of nitrogen in plants;
biodegradation of organic polluants; recovery of biogas and biofertilizers;
production of single-cell proteins for animal feed; production of enzymes
for industrial use, lactic starters, organic acids and antibiotics.
a) Training of human resources.
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182
ECUADOR
NATIONAL PROGRAMME FOR BIOTECHNOLOGY
The National Council of Science and Technology (CONACYT) has
promoted activities on biotechnology since 1983. At the very beginning an
advisory group was created, composed of researchers of institutions
working in biotechnology fields.
Research and development Projects
Human and
Animal Health
Diagnosis
Systems DNA
Probes
Monoclonal
Antibodies
Development
of Vaccines
Agriculture
Plant tissue
Cultures
Environmental
Health
Waste water
treatment
– Aerobic
– Anaerobic
– Biogas
N2 - Fixation
Treatment of
industrial
solid wastes
Nutrional
Absorption
Bioindustry
Production of
basic materials
– Fermentation
– Citric acid by
fermentation
– Glutamic acid
by fermentation
Utilization of
agroindustrial
subproducts
Chart 1. National Programme for Biotechnology
Development of a
technology to
produce alcohol
from
conventional and
unconventional
materials
In the middle-term, there are also, at nation-wide level, projects with
significant economic prospects such as: the animal reproduction through genetic
techniques; the production of hormones, diagnostic kits for plant viral diseases,
secondary metabolites from plant cell cultures, biopesticides for the biological
control of epidemics, and bacterial leaching processes of certain metals.
183
This group has helped to define priority areas and research projects
which need to be developed. On the other side, it has supported the analysis
of propositions made by international organisations, which have urged the
country to adhere to development programmes on biotechnology. In the
policy guidelines proposed by CONACYT, biotechnology is considered as a
scientific and technological priority to solve some of the serious problems
the country is facing, taking into account the unprecedented development of
this sector at international level.
The policy guidelines will be concretized in a National Plan which,
on the one hand, will gather the activities developed in the ‘Grupo
Ecuatoriano de Biotecnologia’ and, on the other hand, will determine
actions directed to the production, application, adaptation and diffusion of
biotechnology in the agro-food and industrial production; and will also
attach health and environment preservation problems.
The National Plan for Biotechnology Development will contain
harmonized programmes as part of the actions to be carried out in order to
reach objectives and goals.
Among the planned programmes, the following ones can be mentioned:
a) Manpower Training Programme, through which a review and
harmonization of the study plans on the basic sciences will be done at
medium and high levels. It will support and fortify the disciplines of
basic sciences in order to provide a basis for the training of human
resources in biotechnology, such as: cellular biology, molecular
biology, biochemistry, biophysics, virology, enzymology, genetics,
microbiology and immunology, at postgraduate level. It will permit the
identification of Master and Ph.D. programmes on biotechnology,
which will be followed by Ecuadorian experts, in the countries of the
region and in the developed countries.
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b) Research and Development Programme, through which the following
points will be carried out: the evaluation of scientific and
technological potential; the survey of research needs on biotechnology,
giving priority to research Unes; identification of research projects on
biotechnology which could be carried out by combined action of both
the university and the industry; backing the foundation of a
Biotechnology Research Centre whose objective will be, on the one
hand, to stimulate the execution of research projects on problems of
social interest, encouraging sectorial biotechnology production, and,
on the other hand, to enrich the manpower training programmes and
provide technical advice on governmental decisions; supporting
research projects planned by institutions and research centres, which
are presently developing surveys.
c) Programme to encourage international and technical co-operation,
aimed to fortify the participation of the country in research projects
on biotechnology, at regional and international levels.
From a strategical point of view, CONACYT intends to defineate the
scientific and technological policies in the sector and the National Plan,
suitable for being applied to the country’s conditions and according to the
evaluation of the scientific and technological potential, in co-ordination
with the ‘Grupo Ecuatoriano de Biotecnologia’, which should be changed
into a Technical Committee.
Concerning the research at present on execution, see Chart 2. Besides,
the following institutions of public and private sectors are developing research,
some of them at industrial and semi-industrial levels:
Instituto Ecuatoriano de Investigaciones Agropecuarias: Merismatic
Culture.
Instituto Nacional de Higiene: production of human vaccines.
INEXA S.A.: merismatic cultures.
LATIN-RECO S.A.: food production.
PRONATEC S.A.: Natural extracts.
Centro de Adiestramiento Lechero S.A.: Lacteal fermentations.
LEVAPAN S.A.: Development of fermentation processes.
Laboratorios farmaceuticos Ecuatorianos (LIFE) S.A.: Production of
animal vaccines.
ALCOLESA S.A.: Alcoholic fermentation of molasses.
185
Chart 2. Current Projects
Institution
Executive unity
Universidad
Central del
Ecuador
Universidad
Tecnica
Universidad de
Guayaquil
Armada del
Ecuador
Research fields
– Histocompatibility
– Immunology and infections
Faculty of
– Development of Bioreactors
Medical Science – Purification of plant dyes
– Purification of fuels
– Fermentation in solid material
– Dairy technology
School of
– Meat technology
Chemical
– Fruit and vegetable technology
Engineering
– Post-harvesting studies of perishable
products
– Larval development of Macrobrachium
penamensis
– Sexual maturing of Bocachico (Bocaccio)
Faculty of
– Sexual diphorism and reproduction of
Natural
Aeuides mivulatus, in aquaculture
Sciences
– Culture of Mytella guyamensis mussel
– Phytoplankton culture
– Sellfish of commercial interest
– Sea phytoplank and primary production
Oceanografic
Institute
– Sea zooplankton
(Division of Sea – Sea Benthos
Sciences)
In order to accelerate the biotechnology development, it is required, on
the one hand, to encourage the training of human resources, strengthening in
this way the country’s scientific level through postgraduate courses in the
countries of the region and the developed countries, and, on the other hand, to
set up a teaching and permanent research programme at under- and
postgraduate levels for the education and training of national researchers.
On that account, it is expected in Ecuador to initiate in 1988 the
postgraduate programme on molecular and cellular biology as basic
sciences in order to develop biotechnology.
At last, research projects to be carried out in the middle term are:
Pharmaceutical products: Nation-wide development of the industrial
production of pharmaceuticals; study of plant active principles and
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their application in the pharmaceutical industry; ‘in vitro’ production
of antibodies from hydridoma to determinate: a) bacterial and viral
antigens through etiopathogenic studies in animals; b) vaccine
production from characterization of surface antigens; c) detection of
blood markers of malignity for diagnosis of tumoral diseases; d)
therapy methods using monoclonal antibodies finked covalently to
drugs in order to attach malignant cells.
Food products: Liquid and solid fermentations for the production and
industrial transformation of food; in high-protein food, it is planned to
carry out genetic modifications of the quinoa to increase its nutritive
value; microbial culture collections: implementation of a microbial
culture collection for the maintenance and distribution of strains of
industrial interest; aquaculture: culture of sea organisms to improve
production and nutritive value of shrimps, oysters and fish; biomass
processes: production of biomass to obtain animal feeding-stuff
biological control of insect vectors: studies of molecular biology,
cellular biology and cytogenetics for the control of the life cycle of
insect transmitters of malaria, oncocercosis, trypanosomiasis; plant
culture: production of vegetable clones to obtain plants with high
productivity and higher resistance to diseases.
Genetic engineering: Interferon production for the treatment of
cancerous diseases. Diagnosis of hereditary diseases through
recombinant DNA techniques.
Environment pollution: Treatment of industrial wastes, especially
waste waters.
P ERU
In Peru, there is a deep gap between the industry sector and the
universities; that is why initial actions of mutual benefit should be started,
and whose quality and quantity would be gradually improved and increased.
On that account, the teaching centres could offer quality control and
advisory services, permitting an ever growing exchange and a real activity
of co-operation in the future. A possible form of this co-operation is the
establishment of industries which, rooted in academic institutions, can
benefit from the human resources, equipment international advisory and
consultancy available for those institutions, and contribute to their entire
work on teaching, research and services.
An important aspect to be considered for the development of
biotechnology in the country is the manpower training. In this direction, the
National Programme must first contemplate the strengthening of different
systems of advanced education (postgraduate courses, professional
specialization, training, etc.), as well as trainee researcher exchange and the
utilization of international and regional co-operation for that purpose.
The Consulting Commission of Biotechnology considers four sectors
in which the application of biotechnology in Peru is of great importance:
Biomedical and Veterinary Sector. There are good reasons to back the
biotechnology development in the health sector. The programme embraces
promising technologies, of fast development, not requiring large investments
for their implementation, depending on the existence of a critical mass of
skilled specialists, and could be established in the present centres wherein
biologists, chemists, pharmacists, veterinarians, biochemical physicians,
microbiologists, immunologists and other researchers are educated and
further trained.
In 1986, the Peruvian National Council of Science and Technology
(CONCYTEC) created the Consulting Commission of Biotechnology to analyze
and propose activities for the application of biotechnology in the country.
It is likely to aim to a nation-wide production of diagnostic elements
of biotechnological origin that will substitute, more or less quickly,
expensive culture techniques and for which basic material is still imported.
Peru is far away from having a critical mass of researchers in this
field. The country requires an adequate co-ordination of the international
organization and the existing research activities for the development of this
field allowing it to reach the phase of goods and services production and to
improve the standard of living of the population.
With regard to therapeutic products, agreements could probably be
concluded to ask national companies to take upon themselves the production
and commercialization of bioproducts and to assume the development and
production of products according to the needs in the near future.
187
Concerning vaccines, the World Health Organization and the PanAmerican Health Organization, working jointly with National Institutes of
188
other American countries, will probably offer consulting services, support
the technological development, set up production lines, quality control, etc.
The areas of major interest are the following:
Diagnosis of enteropathy, tuberculosis, acute respiratory diseases,
transmitted by vectors and parasites;
Thermostable vaccines and new vaccines;
Other biological products such as antidotes, insulin and
plasminogen activator.
Agro-Food Sector. This is a prior-right sector because of the
agricultural situation of the country.
In several points of this sector, the in situ application of
biotechnological processes is feasible, which could incite the development
of rural industries, with a very large social impact. The application of these
processes would also increase the production and productivity of the land.
However, the promotion of a biotechnological agriculture will require a
good control of its production and an appropriately expanded work from the
corresponding governmental organisms.
In the agro-food sector, there are already some experiences and
preliminary results which should be encouraged for obtaining short-term
success, including their transfer to other countries of the region.
Experiences and results within the following areas:
1.
2.
3.
4.
5.
in vitro cultures;
micropropagation and genetic stabilization of plants;
production of basic seeds;
bioconversion of materials and agro-industrial wastes into animal
feeding stuff, enzyme production, alcohols and other chemical
substances;
6. production of biogas and biofertilizers;
7. nitrogen-fixing micro-organisms and mycorrhyzal fungi;
8. production of diagnostic systems for plant viruses.
Chemical and Pharmaceutical Industry Sector. Considering the import
balance of basic materials for the chemical and pharmaceutical industries, it is
essential to substitute imports and to develop the following areas:
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1. alcohol production as raw material for chemical industries
(chemistry of alcohols);
2. production of solvents (butanol, isopropanol, acetone, etc.);
3. production of antibiotics through fermentation and biosynthetic methods
(penicillins and semi-synthetic cephalosporins, aminoglycosides and
rifampicin);
4. production of organic acids (citric, acetic, lactic, fumaric and others);
5. production of essential amino acids (lysine, methionine and
glutamic acid) and vitamins (riboflavin and ascorbic acid);
6. production of steroids (cortisone, prednisone) and other molecules
obtained from yams;
7. production of alkaloids and other substances through vegetable cell
cultures.
Other Sectors. The following four areas are important:
1.
2.
3.
4.
5.
metal extraction from metallic sulphates through bacterial
leaching;
tertiary recovery of petroleum;
biodegradation of pollutants;
monitoring of environmental pollution.
Generally speaking, it is extremely important to carry out in these
sectors a national evaluation of economic, political and technical nature.
In order to set up a programme, the Consulting Commission has proposed:
a) To carry out an evaluation of the national biotechnology, developing
its prospects.
b) To analyze biotechnology abroad at three levels: Developed
Countries, Third World Countries, the Andean Countries.
c) The elaboration and regulation of a policy responding to a national
demand and adjusted to the situation of the country, in order to
reach results enabling the improvement of the standard of life of
the Peruvian consumer. The regulations must include a ‘Patent
Register’ for the protection of biotechnological processes which do
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not have a directly human and social incidence, and, of course,
underline the priority of working areas.
Besides the Commission has proposed:
To create a National Network of Biotechnology as an institutionalized
system of co-ordination and intercommunication, in accordance with the
existing national laboratories.
To recommend the creation of a special fund for biotechnology
research and development, giving to the ITINTEC a part (2%) of the
resources provided by the industry, and thus harmonize research teams,
activate the laboratories of the National Network and encourage
researchers. This fund would be managed by the CONCYTEC.
To promote meetings and communication among entrepreneurs,
researchers and users of biotechnology to make effective the
utilization of the National Network.
It is necessary to clarify to what extent basic materials and scientific
equipment, essential for the development of biotechnology, represent
a significant point in the Peruvian import balance. A strategy must be
planned to put an end to this dependency in order to develop the
national production of these basic materials and scientific equipment.
The permanent problem of imports has also been discussed. By
general consent, CONCYTEC should try to speed up the regulations
concerning customs clearance so as to be able, at least, to receive
radioactive materials with preserved good specific capacity, really
fresh biochemical supplies, laboratory reactives, biologically active
and special strains.
VENEZUELA
The National Programme of Biotechnology was set up in 1984, after the
President of the Republic created by Presidential Decree No. 240 the National
Commission for Genetic Engineering and Biotechnology, within the National
Council for Scientific and Technological Research, to act as an advisory
organism to the presidency of the Republic and to define policies and elaborate
plans for the development of genetic engineering and biotechnology.
The Programme’s main objectives are the following:
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a) To promote scientific and technological research in genetic
engineering and biotechnology areas.
b) To formulate and co-ordinate the National Plan for Genetic
Engineering and Biotechnology.
c) To co-operate with organisms whose task is to promote, plan and
finance the scientific and technological development of the country
in this area.
d) To attempt the establishment of scientific and technological
networks of information on genetic engineering and biotechnology.
e) To spur the training of human resources in this area.
f) To co-operate with organisations which represent the Republic on
international matters; especially when relationships in the
biotechnology area are concerned.
With the aim to get the Programme started, a strategy has been
adopted to sort out projects, including the establishment of research cooperative groups in agriculture, agro-industry, and medicine areas, in which
the participation of the teaching and the industry sectors is expected.
The principal projects of the biotechnology Programme, already
selected, are the following:
Agriculture. Production of potato and yucca mother plants and other
products, through tissue culture techniques, somatic hybridization,
induction and selection of mutants.
Obtainment of pathogen-free plants using tissue culture techniques,
followed by massive clonal propagation and development of diagnostic
reactives for pathogen detection.
Industry. Purification technology of glucose and fructose syrups.
Design and evaluation of processes for the production of fructose syrups.
Agro-industrial waste recovery for the production of protein-rich
animal feed.
Enzymatic degradation of lignocellulose wastes.
Biomedicine. Studies of diagnosis, prophylaxis and epidemiology of
diseases such as: leishmaniasis, trypanosomiasis and leprosy. Research in
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this field will include pathogen isolation and culture, cloning and antigen
identification, obtainment of monoclonal and polyclonal antibodies, etc.
Biochemistry and immunology studies are also planned.
Another group of studies in this area are: Cancer and AIDS diagnosis,
therapeutics and epidemiology. Research in this area could be aimed to
gene isolation, recombination, production of RNA and DNA probes,
oncogens, transformation factors, etc.
SUBREGIONAL E XPERIENCES : PADT-C OBRE AND THE M ININGMETALLURGICAL P ROGRAMME
The Commission of the Cartagena Agreement, by Decisions 86 and
87, approved the Andean Projects for Technological Development in the
Copper area (PADT-Cobre), whose activities started in 1973 and came to an
end in 1981. The general objectives of PADT-Cobre were the following;
a) To form specialists teams, competent enough to generate and improve
technologies applied in the area, from laboratory level to the planning,
design, maintenance and operation of industrial plants.
b) To create in Bolivia and Peru laboratory facilities for the analysis,
evaluation and development of existing studies on leaching of
copper ore.
The projects executed within the PADT-Cobre framework, in which
Peru and Bolivia participated, were:
Project I: Copper-oxide ore treatment through leaching with sulphuric acid
and cementation with scrap iron.
Project II: Bacterial-acid leaching of copper ore in columns or wastes.
Project III: Copper recovery from copper sulphate solutions through ionexchange electro-deposition.
NOTEWORTHY RESULTS IN B OLIVIA
a) Equipment, fitting up, and operation of the laboratory belonging to
the Department of Special Metallurgical Projects of the SubDirection of Projects of COMIBOL, in Oruro.
b) Fitting up of the Krupp pilot plant type 11 for copper recovery
through ion-exchange electro-deposition.
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c) Education and training of 23 specialists, among them engineers and
technicians on acid-leaching technologies; and, on the planning,
design, building and operation of pilot and industrial plants for copper
treatment through hydrometallurgical methods. This technical team has
up-to-now elaborated two studies of feasibility ‘Corocoro’ and
Solivar’, and two of pre-feasibility ‘San Miguel’ and ‘Telemayu’.
NOTEWORTHY RESULTS IN P ERU
a) Equipment, fitting up and operation of the laboratory of the
Department of Metallurgy Research of CENTROMIN, in La Oroya.
b) Plan, design, fitting up and operation of the Pilot Complex of
Toromocho which is composed of 8 copper ore columns with more
than 150,000 MT, reaching, some of them, an extraction rate of 88%
and a throughput of 3.5% per month; a cementation plant of nearly
15 MT per month; and a Krupp plant for ion-exchange electrodeposition with a capacity of 14 MT of electrolytical copper per
year. Approximately 400 MT of copper cement (worth US$470,000)
were produced in the cementation plant.
c) Education and training of 35 specialists, among them engineers and
technicians, of CENTROMIN Peru, Ingemmet and Minero Peru.
In general, the following concluding remarks can be mentioned:
a) The development of PADT-Cobre has permitted the utilization of
technologies in the copper hydrometallurgical area applied to the
benefit of lower-grade copper ore in the following areas: chemical
leaching, ferro-bacterial leaching, extraction by solvents,
cementation, electro-deposition and crystallization.
b) As a result of the above mentioned development, technical and
economic studies have been worked out, such as the planning,
design, building and operation of the Pilot Complex of Toromocho
in Centromin Peru.
c) The mastering of the technologies developed in Bolivia and Peru
will enable their incorporation to the industrial and productive
sector of both countries.
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d) The utilization of technologies developed in the subregion in the near
future will allow the incorporation and development of new sources of
foreign exchange. At the same time, they will have a growing effect,
which will permit a larger industrial activity and the creation of
‘satellite’ services parallel to the establishment of new technologies.
With regard to financing, it is necessary to indicate the support for
technical co-operation, not refundable, from the government of the Federal
Republic of Germany, thanks to an accord with the Cartagena Agreement.
e) The technological achievements attained through the concerted effort of
the Cartagena Agreement and the Member Countries, in the present case
Bolivia and Peru, are a clear example of what can be reached by means
of a clearly defined technological integration policy provided with
mechanisms and tools for its efficient application.
The Andean Council for Science and Technology (CACYT) strives to
promote, at subregional level, an adequate scientific and technological
capacity to satisfy the demands for economic and social development of the
Member Countries (Decision 213).
f) The adopted technologies open the way to recover copper and other
valuable metals from lower-grade ore constituted by out-falls,
effluent residues, wastes, etc. Two million tons of lower-grade ore
has been estimated in Peru and Bolivia. The acquired technological
knowledge will permit not only a more important income for both
countries, but also a great contribution to fight environmental
pollution provoked by traditional mining methods.
On basis of the experience above described, the Cartagena
Agreement began in 1985 the development of the Andean MiningMetallurgical Programme (PMMA), whose general objective is to strengthen
the technical and economic integration of the mining-metallurgical sector of
the Andean subregion.
Particularly in the bio-hydrometallurgical area, work is at present
carried out on technology transfer of bacterial leaching, obtained during the
PADT-Cobre, and its application for polymetallic extraction. On the other
side, research on the application of other hydro-metallurgical technologies,
which will permit the recovery of other metals, is on the way.
These activities are possible because of the consolidation of the
research and application centres for this technology in the Member
Countries, and of course the training of human resources.
The technologies constituting this programme, will be applied in
deposits chosen by the Member Countries.
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T HE ANDEAN COUNCIL FOR SCIENCE AND T ECHNOLOGY AND THE
CONCERTATION OF ACTION ON B IOTECHNOLOGY
The CACYT is composed of top authorities responsible, in each one of
the countries, for the scientific and technological system and the orientation
of activities considered in the ‘Caracas Programme for Co-operation on
Research and Scientific and Technological Education and Training’
(Decision 183).
During its second meeting (La Paz, 1984) the CACYT recommended to
enter upon biotechnology all together, and also sup-ported the creation of a
work team composed of Colombia and Venezuela in order to elaborate
preliminary actions, initiating a process of concertation and programming.
To achieve its goal, this task took form at the ‘Cucuta Meeting’,
celebrated between both countries in September 1986; further details will be
given in the next section.
Another source of discussion for concertation on biotechnology
during the Fourth CACYT (Caracas, 1986) were the topics identified in the
national plans for Science and Technology, by means of a document
prepared by the Cartagena Agreement.
The Fourth CACYT adopted the idea of ‘problem-areas’ in order to
identify action lines and to programme, at the first phase, joint activities on
biotechnology.
In the health area: Tropical diseases, malaria, Chagas’ disease and
leishmaniasis were considered as targets for biotechnology applications.
In the agriculture area: The improvement of productivity through
nitrogen fixation and micropropagation of pathogen-free plants were
considered as priority lines.
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In the agro-industry area, priority was given to the improvement of
nutrition through the production of protein-rich food.
Chart 3. The Cucuta Meeting: outlines for specific projects
Biotechnology on Health
In the natural resources area, an adequate utilization of natural
resources will allow work on biotechnological research, and especially in
fields related to promising products, treatment of waters and wastes.
Utilization of biotechnology for the development of detection techniques of leishmaniasis.
In the energy area, the development of new sources, such as those
generated by biomass, was considered as a priority for the first stage.
1.
2.
The Fourth CACYT recommended that the programming of scientific
and technological activities on action lines above mentioned, must arise
from the necessity to link research and production, and to take advantage of
the Andean growing market to boost intensive products in technology, and
fixing the financial mechanisms to obtain them.
3.
4.
T HE COLOMBO-VENEZUELAN MEETING ON B IOTECHNOLOGY IN HEALTH
AND A GRICULTURE AREAS
The Colombo-Venezuelan Meeting on Biotechnology in the health
and agriculture areas, sponsored by the CACYT, was held between the 18th
and 20th September 1986. Delegations of each Member Country presided by
the top governmental authorities on scientific and technological policy, the
Ministry of Science and Technology of Venezuela and the Director of
Colciencias. Representatives of the Cartagena Agreement, EEC and BID
attended the meeting too.
The participants contributed to the elaboration of specific project
outlines intended to apply biotechnology in the health and agriculture areas
through the creation and support of a series of co-operative networks to which
other Member Countries would be later invited to participate in (see Chart 3).
The Programme’s main objectives will be the expansion of the
scientific and technological capacity on biotechnology and the potential
market for the products resulting from its application; obtainment of
products and services of significant economic and health interest for the
subregion; and the co-operation on education and training of human
resources to attain these goals.
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Project I Leishmaniasis
Subprojects
Standardization and production of leishmania for diagnosis and prognosis of leishmaniasis.
Employment of DNA probes for identification and classification of leishmaniasis in
vectors, for epidemiological control.
Use of monoclonal antibodies for identification, diagnosis and prognosis of leishmaniasis.
Isolation and characterization of specific antigens of leishmaniasis for diagnosis
Project II Creation of New Techniques for Diagnosis of the Chagas’ Disease
Project III Diagnosis of Malaria
Subproject A: Entomological diagnosis.
Subproject B: Human blood cell screening.
Project IV. Animal Health
Subprojects
1.
2.
3.
4.
5.
Bacterial and viral agents affecting bovine reproduction, brucellosis, bovine viral
diarrhoea, bovine rhinotracheitis.
Hemoparasites, babesia and anaplasm.
Vesicular diseases, vesicular stomatitis and foot-and-mouth disease.
Viral agents provoking diarrhoea in porcines, bovines (rotavirus, reovirus).
Viral agents affecting poultry raising.
Biotechnology on Agriculture
Project I Tissue Culture
Subprojects
1.
2.
3.
4.
Selection and programming of promising banana clones of regional interest for Colombia
and Venezuela.
Production of healthy potato plants for sowing.
Development of methodologies for clonal propagation of cacao.
Development of a technology for pelleting embryos produced ‘in vitro’.
Project II Diagnosis and Prevention of Viral Diseases in Food and Industrial
Cultures
To that effect, it has been suggested the creation of an integrative
programme embracing the different aspects of co-operation in the area, and
precluding the arise of a package of independent specific projects. A twofold objective is in mind to face mutual deficiencies which would hinder the
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success on the intended projects, and allow the introduction of new
products as soon as areas of interest for regional concertation are detected.
The programme will probably last four years in order to enable the
harmonization of the goals fixed in projects initially chosen and those
which could be introduced in the programme’s first stage.
The programme is subdivided in three subprogrammes: (a) human
health; (b) animal health; (c) education and training of human resources and
scientific exchange. The first two subprogrammes embrace a series of
specific projects in their respective areas. Priority was given to these
projects because of the available information in the First ColomboVenezuelan Meeting on Biotechnology, but the introduction of projects for
co-operation by well-known laboratories in both countries in areas not
considered within the first stage, will be accelerated.
Every financed project will be directed by a co-ordinator appointed by
the heads of the participant laboratories, and its execution will be periodically
evaluated according to international rules, employing as far as possible
technical commissions and the mechanisms established to follow up
programmes for international co-operation by CONICIT and COLCIENCIAS,
including the help, if necessary, of international experts.
The manpower training and scientific exchange programme will
embrace the usual activities in this area trying to harmonize the respective
needs of the specific projects and, in more general terms, the goals of a
programme for integrative development of biotechnology. To that effect,
mechanisms to ease the research exchange between Colombia and
Venezuela will be established, and also the use of courses and training
programmes of common interest.
The three subprogrammes will be run by an ‘ad hoc’ sharing
Committee created by CONICIT and COLCIENCIAS and will oversee the
accomplishment of objectives and the attribution to each sub-programme of
the necessary resources.
T HE B IOTECHNOLOGY P ROGRAMME OF THE ANDEAN CORPORATION FOR
DEVELOPMENT (CAF)
In order to contribute to the development of biotechnology in the
countries of the Andean Group, through support to the research areas and
spurring the creation of structures which will permit to link research results
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to the producing activity, the Andean Corporation for Development adopted
a programme that will enable:
a) To promote communication among specialized research centres and to
stimulate the exchange and harmonization of research and information.
b) To back the development of specific projects of applied research with
the purpose to settle the ground for a more self-sustained development.
c) To support the constitution of operative structures that will bridge
research sectors and users. (For instance, facilitating the association
of research groups, farming centres and private enterprises.)
d) To support the establishment of enterprises specialized in the
culture, propagation and commercialization of plants obtained by
biotechnology applications.
e) To organize programmes for the education and training of the
personnel, to ease technology transfer and advisory.
In the first phase, the programme will concentrate on the tissue
culture area.
Selected research centres or companies carrying out or conceiving
biotechnology projects will be supported. Choice or selection of projects
will basically depend on the degree of their practical use.
Support will include personnel training and specialization, as well as
technical assistance and consulting services. It will also include the
equipment and the supply of research material. Concerning training and
equipment areas, an important task has been planned: the search of support of
international organisms in order to reinforce the CAF possible contributions.
At later stages, and after evaluation of the initial actions, new areas of
biotechnology and genetic engineering will be introduced according to
applicability and utility criteria.
The programme is expected to carry out the following main activities:
1. The establishment of an inventory of the subregional capacity in
biotechnology, including:
a) Research areas.
b) Availability of laboratories.
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c) Availability and needs of skilled personnel.
d) Degree of application and present and potential use of biotechnology
in the productive sector.
2. Selection or choice of programmes or projects, actual or in course
of preparation.
3. Organization and outset of the projects.
4. Organization of a specialized seminar at subregional level.
5. Intervention before international organisations to obtain support on
personnel training, consulting services and equipment.
6. Evaluation of the programme’s results after the first year of operation.
The program will last two years and cost US$1.0 million that will
finance the following activities:
a) Inventory of the subregional capacity in the biotechnological sector.
b) Further development and identification of biotechnology
programmes or projects.
c) Organization of meetings and specialized seminars at subregional
level.
d) Promotion of participation of specialized international agencies
in the programme.
e) Budget support to specialized centres on biotechnology in each
country of the subregion.
The programme will be financed with resources of the Fund for
Development of Genetic Engineering and Biotechnology in the Andean
Group. The Assembly of Shareholders of the Andean Council for
Development (CAF) has been urged to create the above mentioned fund, and
to grant it US$1.0 million from the accumulated net income of the CAF on
the 31st December 1986.
The programme will be conducted by a unit specially created to that
effect and composed of the Head of the Programme, one or several
consultants, according to needs, supplied without any cost for CAF by
specialized governmental or international agencies, and a secretariat.
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2.4.6. Andean-European Co-operation on Biotechnology
A future Andean-European Co-operation in the biotechnology sec-tor
may rely on the Agreement for Co-operation signed by both integration
groups. To that effect, it is convenient to identify the main points of the
above mentioned Agreement.
The Agreement has a global and integrative conception of cooperation which is defined as ‘a broad economic co-operation to
contribute to the development of the Parties respective economies and to
raising their standards of living’. It is no longer something as punctual as
the supports the EEC was offering to certain sectors in the past. The
Agreement’s global task is to spur more adequate stages according to the
degree of maturity of both integration processes: it opens an ambitious
outlook with far-reaching effects.
A ‘more equitable distribution’ of development potentials encloses a
redistributive criterium maintained by the Andean Group and must lead to
the planning of operation in which science and technology transfer would
play an important role; and this because of the arrangements and
commitments for teaching and transmission stated in the Agreement. The
Agreement must therefore serve as an ambitious instrument for
redistribution at subregional level.
To recognize that the Andean Group is made up of developing
countries, and within it of less-developed countries, is to give to Bolivia and
Ecuador a special treatment, above all in the education and training.
The co-operation for development enunciated in the GRAN/EEC
Agreement recognizes the necessity to co-ordinate EEC member states
efforts to back integration projects, in the present case scientific and
technological. For the Andean Group it implies a larger capacity of
harmonization and concertation so as to enable the integration projects to
seize major opportunities which will probably be carried out by means of
the European effort for co-ordination. The resulting rationalization should
be considered as a growing and profitable potential which will depend on a
more active and efficient position of the Andean Group during the
execution of the Agreement.
Scientific and technological co-operation was sometimes confined
to certain activities with detriment to others, to public agents
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disadvantaging the private sector. The Agreement explicitly embraces
co-operation in the fields of science and technology, industrial
development, agro-industry and farming, mining, fisheries, infrastructure, transport and communications, energy and tourism. The
possibility to form joint ventures was not considered by the GRAN/EEC
co-operation in the past. This leads to the necessity of seeking synergetic
effects. Science and technology, as proposed by the An-dean strategy,
must be the common denominator to all the sectors affected by
modernization processes within the framework of the Andean Strategies
for Science and Technology. Knowledge becomes the key to the whole
integration process in various areas.
personnel education and training area which could become one of the most
important channels for capacity transfer from the EEC to GRAN.
An unavoidable subject which has been discussed for a certain time
by the GRAN member countries and in consequence has been approved as a
Special Fund by Decision 183, is the organization and setting up of a
financial mechanism to support joint actions. The precise identification of
mechanisms for co-operation will come to light from the experiences and
opinions exchanged during the European/Latin-American Seminar.
Concluding Remarks
a) We face an Agreement whose potential must be ambitious in its
far-reaching effects. It may be used, within the present crisis, to
transfer of knowledge and capacity necessary for the Andean
Group for a more self-sustained development.
b) It is important to point out mechanisms or tools from the
GRAN/EEC Agreement to make viable the knowledge and
capacity transfer, and realized through the co-operation above
indicated or in exclusively detailed activities.
c) The Agreement requires an explicit and feasible action framework for scientific and technological co-operation.
d) Completing this idea, a strong support would be given to the
relationship of horizontal co-operation among the GRAN member
countries in order to create a joint action through resources,
capacities and abilities from the EEC.
The GRAN and EEC Member States must come to understand each
other’s experiences in science and technology. Priority is placed on the
better understanding of the rationalization and canalization of recent
resources in order to create a new and more integrative cooperation scheme.
GRAN is stepping towards a scheme of harmonization and concertation
of needs and will, soon be ready to initiate this task. The subregion’s
‘harmonized’ demands are already known, particularly in the subregional
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HEALTH IN THE THIRD WORLD:
THE ROLE OF INTERNATIONAL CO-OPERATION
Luiz Pereira da Silva
Expectations of the benefits from the introduction of new
biotechnologies on the health of people in the third world is reflected in the
immense publicity given to them not only in the specialized press but also
in the mass media.
Therefore, it is not necessary here to re-emphasize the new possible
applications to health sciences provided by DNA recombinant techniques,
molecular genetics, monoclonal antibodies and other modern techniques for
the diagnosis, prevention and treatment of human diseases.
Taking for granted that most if not all of the people in the audience
are aware of these potential benefits, the speaker is more inclined to discuss
a few general points related to the introduction of new biotechnologies in
the third world. By assuming an ‘against the stream’ attitude, the speaker is
conscious of the fact that he will probably be considered as having
conservative views. He accepts this blame and asks for the comprehension
of his younger colleagues.
The speaker will try to define some problems which he thinks are
specific to third world conditions, to raise some questions on the
introduction of new biotechnologies and to develop arguments in favour of
particular policies he thinks must be followed by govern-mental agencies,
either national or international to provide a rational basis for the use and
development of biotechnologies. Finally, he will try to define the type of
international co-operation that he thinks could contribute to accelerate
socio-cultural progress in the third world and would lead to an improvement
in the infra-structure necessary for the development of health policies.
Specificity of Third World Problems
The first thing to define is the existence of specific problems of
health in the third world. They consist first in the nature of the health
problems: malnutrition, high incidence of infectious and parasitic diseases,
high rates of maternal, neonatal and infantile mortality, low quality and
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insecurity of housing and working conditions, with high incidence of
accidents. Most of these problems, which drastically decrease the
expectation of life and seriously deteriorate the living standards are
determined by social and economical structures. Medical care measures are
only of limited effect and correspond to the use of traditional products like
antibiotics and chemical drugs.
The second important feature of health problems in the third world is
the inadequacy or absence of the structures necessary to provide health
care: hospitals, welfare centres, and the low (or insufficient) qualification of
the staff responsible for health care. In respect to the subject discussed here,
namely the introduction of modern biotechnology in health sciences and in
medical practice, one important deficiency is the absence of national
pharmaceutical and chemical industries for drugs and pesticides in most
countries of the third world and the weakness or absence of a biological
industry for vaccines, sera and blood products and derivates. As a
consequence, all the medical measures of the health policies in the third
world, from the public health level to the private clinical medicine are
entirely dependent on the importation of technology in the form of drugs,
products, machines and equipment.
A Rational Policy for the Introduction of New Biotechnologies
With this picture of the health problems in the third world we will try
first to describe some errors and illustrate how they can be avoided.
1. New biotechnologies cannot, in any case, replace measures at the
social-economical level responsible for the basic problems of health.
2. New biotechnologies are not obligatorily giving the best solutions
for health problems in substitution to traditional biotechnology.
3. New biotechnologies cannot (or are difficult to) be introduced
independently of the complex economical and technological infrastructures necessary for their functioning.
4. New biotechnologies cannot be employed out of context of a solid
scientific environment and a precise evaluation of interdisciplinary
and technological interactions.
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5. New biotechnologies will not be an area in which can proliferate
small new enterprises full of original ideas and opening fantastic
opportunities for imaginative young people.
6. New biotechnologies applied to health will not be an area of
activity from which important financial benefits are to be expected.
After having considered all of these negative views on the use of new
biotechnologies in the third world, the speaker will discuss some positive
ones which are important:
1. Some of the important problems of public health in the third world
would benefit enormously from the introduction of new
biotechnologies, like for the diagnosis and prevention of hepatitis,
malaria, AIDS and other diseases.
2. Most of the countries in the third world, in addition to a majority of
poor people, have also a fraction of the population with relatively
high socio-economic conditions, and consequently health problems,
equivalent to those of developed countries.
3. The absence of strong local industry occupying areas of economical
activity and using traditional technology liberate countries of the
third world from conservative pressure of lobbies.
A rational policy on the introduction of modern biotechnologies in
health sciences and in medical care in the third world must take into
consideration both the positive and negative constraints discussed above.
According to the speaker’s point of view it must respect some basic points:
Development of scientific and technological education, scientific
and technological research without any dicotomy but looking for
equilibrium and association of both activities;
Acurate planning of investments to provide, through the
development of economical and technological backgrounds, the
opportunity for the flowering of different innovation;
Stimulate the participation of the scientific community through an
open and large debate on selecting priorities and choosing
technological alternatives;
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Define social priorities and integrate public health programs in a
general project of socio-economic development.
International Co-operation
The difficulty in defining a rational model for the development of
international co-operation in the area of new biotechnologies is the
difficulty in defining the protagonists. Since technologies are finally to
produce goods and since the production of goods is a function of Industry,
‘new biotechnological products’ are as result produced by the different
branches of the ‘Industrie de pointe’ in Pharmacy, Chemistry, Mechanics,
Electronics, etc. As we know these industries are nowadays developing a
tremendous international commercial war for conquering markets. To create
artificial needs is often more important than to satisfy a real necessity.
Marketing is more decisive than scientific accuracy.
The past experience of the third world of co-operation in Industry is
quite negative. The example of what happened with the pharmaceutical
industry in Latin America in the 1960s is illustrative. During the Second
World War, and in the years just after, many Latin American countries had
developed a promising pharmaceutical industry. This, however, collapsed
when confronted with the multinational enterprises invading the market
during the economical ‘boom’ of the 1960’s which offered a series of new
products like antibiotics, neuroleptics, tranquillizers, etc. (which, of course,
were all covered by patents).
If we wish to avoid the repetition of this phenomenon with new
biotechnologies we need to have very clear ideas on the mechanisms by
which international co-operation and technological and commercial
exchange must be oriented. For the moment there is no reason for an excess
of optimism, since all the available indicators point to an undesirable
evolution and this for a series of reasons:
New biotechnologies and their derived products applied to health
sciences and medical care are more and more the ‘affaire’ of giant
chemical-pharmaceutical enterprises, which are normally more
interested in selling products than in transferring know-how. In
the 1970s we observed the creation of a large number of new small
enterprises dealing with biotechnology, especially in the USA but
also in Europe, nowadays most of them have disappeared or have
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been absorbed by the giant industrial conglomerates either
national or multinational.
To regulate the exchange of technologies between developed
countries and to conciliate conflicts arising from the industrial and
commercial activities of national and multinational giant
enterprises, European countries have created structures at the
supranational level, like the EEC, which have all the political
support from national governments and which are provided with
the necessary social, political and economical authority to
guarantee and support their role.
Apart from some political tribunes in United Nations, there is no
equivalent international organisations to regulate the interactions
and exchanges among developed and underdeveloped countries
with the exception of those in charge of the police supervision at
the financial level like IMF.
In these conditions it is easy to realize that free direct interactions
between industrial protagonists, bringing together, on the one side
experienced giant enterprises and on the other inexperienced small
and poor companies will more often generate good business for
the first than useful technological transfer for the second.
Therefore, the natural tendency of trade, interactions and ‘cooperation’ will be (and already is in many respects) the invasion of
nascent markets in the third world countries by commercialized
products, either imported or produced by local subsidiaries of
multinational enterprises. They will satisfy the needs (real or
artificial) of the fraction of the population referred to above as being
similar to the consumer society present in developed countries.
If following this model, transfer of new biotechnologies will
reinforce economical and technological dependence, create artificial social
needs, create foreign commercial exchange imbalance and deform the
priorities of national health policies.
The only way that third world countries have to protect them-selves
against all these negative consequences of ‘free exchanges’ and ‘open
borders’ is to refuse them and to regulate the international co-operation
according to their national interest and health policies.
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Conclusion
The speaker has already defined some of the main principles he
thinks must be followed by third world countries in order to favour a
rational introduction of modern technology obtained from developed
countries.
If we assume that all men are alike and that all of them would benefit
from a general improvement in the health of the third world, then it is
possible perhaps to express some wishes concerning practical
recommendations that could be addressed to the EEC to favour know-how
transfer in the area of new biotechnologies.
Creation of permanent bilateral structures between EEC and the
equivalent regional inter-governmental organizations, for the
study, regulation, financial support and control of technological
transfer projects.
Developing and amplifying the already existing programmes of
scientific co-operation between third world and European
laboratories. Give priority to institutions of the third world directly
involved in research in health sciences to allow them to elaborate
new adapted techniques and products.
Developing programmes of scientific and technological training for
third world students giving preference to projects conducted in local
laboratories and institutions. The organization of permanent
summer schools with a minimum of permanent administration and
the participation of relevant European technicians and scientists
would be a welcome formula.
Elaborate programmes to drain the surplus of trained people in
Europe to work for periods of one to a few years in laboratories of
the third world with financial support from the EEC or international
agencies. In this respect, a welcome initiative would be to stimulate
well-trained young Europeans, during their military service, to go to
work in third world laboratories.
All these and other possible initiatives might be developed in coordination with WHO and their regional agencies. A dose interaction with
parallel projects related to agriculture would certainly increase their impact.
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Community. SOBELA was an impressive demonstration of the will of all
parties concerned to meet this challenge.
CONCLUSIONS AND ANALYSIS
Bernardo Sorj
The three days of discussion confirmed the importance of
biotechnology for Latin America not only in such fields as tropical
medicine and nutrition which are vital to basic welfare, but also in areas
directly contributing to economic growth and development.
Biotechnology has a role to play in strengthening Latin America’s
growth prospects and trade performance by:
improving crop yields;
favouring import substitution in agriculture and industry;
extending the pharmaceutical industry into new areas;
and, perhaps above all, capturing the creativeness and
entrepreneurship of Latin America’s smaller technology-based firms.
If these hopes are realised biotechnology will feed into structural
adjustment efforts and so contribute to relaunching growth, and overcoming
the debt problem.
But these hopes will not be realised overnight:
there is a shortage of scientists able to place the necessary expertise
at the service of Latin American industry;
research institutes and universities cannot keep pace with the
demand;
information concerning available technologies which could be
adapted to the needs of Latin American industry and agriculture is
lacking;
smaller firms possessing such technologies in Europe and elsewhere may, because of their size, lack the means to establish
contacts with counter-part firms in Latin America.
This situation poses a challenge to research institutes, industry,
governments, regional organisations in Latin America and to the European
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Where do we go from here, now that a certain number of contacts
have been made? What can Europe and Latin America do, working together
as partners, to further co-operation in the field of biotechnology? How in
particular can the Community, by virtue of its own experience in promoting
cross-national research on biotechnology and more generally of economic
co-operation help assure a follow-up which is worthy of the many valuable
interventions made at the seminar?
There are at least three fields which call for immediate action:
A. Information. The improvement of the two-way flow of information
between Europe and Latin America on new developments in
biotechnology: the Commission is ready to explore possibilities for
improving data bases, facilitating exchanges between research
institutes, organising specialised seminars and conferences to
ensure that researchers in our two continents are informed of each
others efforts, within the normal constraints imposed by
commercial considerations;
B. Training. Latin America is producing an increasing number of
scientists but their number falls short of that required by the rapid
growth of biotechnology.
The Community and its Member States can help overcome this
problem by:
making available experts to work with Latin American research
institutes and biotechnology-based enterprises;
arranging traineeships for Latin American scientists with
Community firms and research institutes;
providing assistance for Latin American biologists to pursue
advanced studies in Europe;
improving information on training possibilities throughout the
Community.
C. Industrial Co-operation. These three days’ discussion have shown
that both sides have an interest in joint ventures and other forms of
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collaboration between firms and research institutes on either side
of the Atlantic. Such arrangements are among the most effective
instruments for technology transfer.
The Commission has recently proposed to the Council that henceforth the Community should do more to promote industrial co-operation
with enterprises in our partner countries in Latin America and elsewhere in
the developing world.
We will examine together in the coming months how best these ideas
can be applied to the field of biotechnology.
You can rest assured that the European Commission will do whatever
is within its power to support those efforts which you, who are dose to the
reality of industry and research, decide jointly to undertake.
Together we will examine the kind of instruments by which we could
develop and implement joint initiatives in the fields covered by this seminar.
For us this seminar has served as a valuable learning experience, an
example of the kind of initiative which can help bring researchers and
industrialists in Europe and Latin America closer together.
The many suggestions put forward will help us to develop new forms
of co-operation not only in biotechnology but also in other advanced fields
where Europe and Latin America can learn from each others’ experience.
SOBELA
questionnaire distributed to Latin American delegates both before and after
The following table shows the level of response.
SOBELA.
Table 1. Questionnaire replies.
Country
Delegates
Replies
Percentage
Andean Pact
9 (11)*
4
45
Argentina
10
6
60
Brazil
17 (26)*
11
65
Mexico
5
3
60
Totals
41 (52)*
24
59
* The number in parentheses includes journalists and governmental representatives, not
directly involved in biotechnology.
The number of co-operation proposals advanced by each delegation
attests to a broadly similar level of interest. If numbers are extrapolated to
include all delegates from Latin America some 200 proposals for cooperation may have been initiated.
Table 2. Co-operation proposals by delegation.
Country
Total
Extrapolated total*
Andean Pact
28
58
Argentina
23
38
Brazil
36
56
Mexico
10
17
Totals
97
169
*extrapolation to 100% rate of reply for each delegation.
Average proposals per delegate
6.4
3.8
3.3
3.4
4.1
The following table summarizes proposals on a country by country
Analysis
basis.
Advanced technologies pose new challenges for developing countries
and their relationships with the developed world. How can high technology
be integrated into a development strategy? What is the best basis for cooperation between Europe and Latin America in the context of a global
market challenged by Japan and the USA?
It is the belief of the Editors that the SOBELA seminar and this volume
provide some valuable indications of how the preceding questions might be
addressed.
SOBELA was organised in two parts: the meeting itself and a number
of satellite visits to European countries by members of the Latin American
delegations. Proposals for possible co- operation were evaluated by a
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Table 3. Co-operation proposals, synopsis.
Countries
B
F
GR NL IRL
Andean Pact
6
4
–
2
1
Argentina
6
7
–
1
–
Brazil
12 11
1
7
–
Mexico
2
–
1
2
–
Totals
26 22
2
12
1
I
4
–
–
–
4
P
–
–
2
–
2
E
2
1
1
2
6
GB
1
7
1
1
10
D
5
2
2
1
10
LA
2
–
–
1
3
Total
27
24
36
10
98
The above figures reflect the special efforts made by Belgium, France
and the Netherlands who organised visits within their countries for
members of the Latin American delegations. Although the United Kingdom
did not host any visits it is notable that a strong tradition of co-operation
served as the basis for a number of proposals.
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Table 4. A sectorial analysis of replies.
Countries
Health
Agro
Energy
Andean Pact
8
6
–
Argentina
10
4
–
Brazil
4
24
1
Mexico
1
4
–
Totals
23
38
1
* Refers essentially to training programmes in relevant fields.
Others*
13
10
7
5
35
Total
27
24
37
10
38
There is a clear division of interest among the Latin American states,
with Argentina and the Andean Pact focusing on Health Care and Brazil
and Mexico focusing on Agriculture. Almost half of the proposals related to
agriculture and a quarter to health care.
The type of European institution interested in co-operation with Latin
America is indicated in the following table.
Table 5. European Institutions interested in proposals.
Countries
Private
Public
Andean Pact
3
24
Argentina
11
13
Brazil
21
16
Mexico
4
6
Totals
39
59
Total
27
24
37
10
98
Overall there was a balance between private and public sector
proposals for co-operation. The Brazilian delegation, which included a
significant number of entrepreneurs showed the greatest tendency to private
industrial co-operation.
It is still unclear how many of these early overtures of interest will
ultimately become manifest as contractual agreements. This will depend in
some measure on the active involvement of states and individuals in
initiatives discussed in the concluding remarks.
A most important consequence of SOBELA was the stimulation of an
identity amongst those Latin American institutions involved in
biotechnology. Strong institutions, both public and private, are of
fundamental importance in promoting and sustaining European/ Latin
American co-operation. It is important to note that the timing of SOBELA in
April 1987 was critical, coming just as Latin American countries were
taking the first steps in the establishment of private and governmental
enterprises in the field of biotechnology. Brazil had just launched the
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Association of Biotechnology Enterprises (ABRABI). The National
Secretariat of Biotechnology of the Ministry of Science and Technology, in
its second year, was defining its programme of activity. Argentina, with a
lesser degree of institutionalisation, had a government body responsible for
promoting biotechnology, and a forum for encouraging the interaction of
entrepreneurs. Mexico has long had government sponsored activities in
biotechnology, but no private industrial sector of note. The Andean Pact
countries are only now formulating their biotechnology programme.
The first important, and unforeseen, role of SOBELA was to crystallise
the institutionalisation of Latin American biotechnology. The seminar
functioned both as a Latin America/Europe meeting and as a rare Latin
American forum, where representatives from the differing Latin American
states were together able to discuss strategy. Thus SOBELA stimulated not
only inter-continental co-operation, but also intra-continental co-operation.
The massive Brazilian delegation probably had a stimulating effect on the
other Latin American delegates, especially in the sense of emulating the
Brazilian association of enterprises with its large private sector representation.
SOBELA fulfilled a second role in indicating a ‘modus operandi’ for
European/Latin American co-operation that may surmount many of the
problems encountered in such international co-operative ventures. The
inclusion of representatives from government, industry and research
institutions allowed the different influences to counterbalance and
complement each other. Too often there is a tendency for policy makers to be
rhetorical, entrepreneurs narrow minded and academics unrealistic. In Latin
America, political instability and sometimes ideological pressures, can
increase those tendencies. It is fundamental that all sectors work together to
ensure the continuity and efficacity of international co-operation.
As an exercise in awareness SOBELA filled a third role, allowing
Latin American and European delegates to evaluate the advantages of cooperation. Latin American delegates were most enthusiastic as exemplified
by the following comments:
‘We felt that Europe is capable of confronting America and Japan
at the scientific and technological level’
‘SOBELA was the first but important step in a difficult, time
consuming, process’
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‘European-Latin American relations should be based on a fair
exchange by which the first receive technology, and the second an
important consumer market’
‘The formation of human resources is a central interest for Latin
America and a precondition for the effective absorption of
European technology’
‘We need to create direct links between European and Latin
American entrepreneurs’
‘We need greater selectivity in the field of industrial co-operation,
taking into consideration existing infrastructure, markets,
technical capacity and patent laws’
‘We need to study the mechanisms by which Europe increases the
links between enterprises and universities’
‘We need to consolidate realistically our national programmes of
biotechnology in order to make clearer what we need and have
to offer’
‘We need to discuss negotiation models capable of satisfying the
expectations of both sides’
‘We discovered that Europe has technologies that will find their
ideal application in Latin America’
‘European documents related to legal problems, regulation and
promotion of biotechnology should be diffused and a workshop
organised on specific topics of common interest’
‘I was impressed by the diversity of interest and idiosyncrasies of
the various European countries, and at the same time by their
conviviality within a common framework’
‘SOBELA was important for us (Andean Pact) because we are in a
stage of definition of our national programme and priorities’
‘The interpersonal relations established during SOBELA will be
central to our future co-operation with Europe. SOBELA expressed
the will of the Commission to increase links with Latin America.
217
These efforts should have continuity through open communication
channels, and the realisation of new meetings’
The Challenges
The quality and quantity of contacts that were established between
Latin American and European biotechnology entrepreneurs, and the facility
with which they were set up indicate that the biotechnology sector is
particularly well placed for the development of economic co-operation
between the two continents, especially between small and medium scale
enterprises (SMEs). The reasons for this lie in the special nature of
biotechnology based SMEs. Relatively small amounts of capital are needed to
launch a joint venture operation, and importantly company directors often
have an academic back-ground with international languages and experience.
In a sector where industrial and academic skills are highly integrated
it is possible to exploit the well established international programmes in
scientific training and research to the benefit of science based commercial
development. SOBELA raised the prospect of using biotechnology as a tool
for promoting international co-operation. Many problems still exist and will
need to be resolved if effective inter-continental partnerships are to be
effected. It will be critical that in such relationships a fair exchange is
effected: for European firms, a reasonable return on investment and
presence in a developing world market, and for Latin American countries
and organisations, the production of essential goods within the framework
of a favourable technology transfer and co-operation environment.
In order to advance the interests of both sides further exchange and
experience is required. The controversial topic of patent legislation must be
confronted. This topic is a subject of debate in Latin America, and indeed
the world press. The USA has recently adopted a most hostile stance towards
Latin American latitude on the patents issue. Internal debate is moving
towards a consolidation of opinion and in some states, Mexico for example,
legislation is being enacted to give full patent protection to pharmaceuticals
and food products. Europe should seek active participation in these
discussions, at European Commission, national governmental and industrial
levels, thus shaping Latin American positions for the future. This will not
be achieved by confrontation and polarisation, but by exchanges of opinion
and political concertation.
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Europe’s presence in Latin America is mediated predominantly by
large companies. There is however much scope for the active participation
of European SMEs, which are usually more open to the technology transfer
schemes expected by Latin American countries.
Increasing co-operation between European and Latin American SMEs
is a difficult objective to realise, not least because of limited information,
provincial attitudes, and simple ignorance of the scope of possibilities for
international co-operation. On the basis of arguments presented in drafts of
this volume the European Commission will explore ways to make available
the information, interface operational units and concertation activities needed
to transform the spirit of SOBELA into a permanent and expanding reality.
SOBELA was not simply a seminar on biotechnology in Europe and
Latin America held in April 1987. It is an ongoing activity, in which Europe
is demonstrating its capacity to be the active partner and focal point for the
constant effort needed to turn around the economies of developing countries
through the medium of high technology.
219